Clinical Research: Available Trials

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CMOH offers clinical trials through US Oncology Research, one of the largest community-based research programs in the U.S., with over 60 research sites. US Oncology Research has enrolled over 80,000 patients in clinical trials and played a role in nearly 100 FDA-approved cancer therapies.
Throughout the last century, the medical community has witnessed dramatic changes in the methods of diagnosis and treatment of cancer. Cancer research is no longer conducted exclusively at large university cancer centers or major metropolitan hospitals. CMOH's physicians have embraced clinical cancer research as a critical component of community-based oncology care. Through a partnership with The US Oncology Network.  You do not have to leave the area to receive premier cancer care.

 If you are interested in learning more about our research program, please contact (215) 658-7240. 

CMOH OPEN TRIALS AS OF April 12, 2021:
CONTACT BECKI BANAS FOR PATIENT SCREENING OR ANY ADDITIONAL TRIAL INFORMATION
BECKI.BANAS1@USONCOLOGY.COM
215-370-6701

IMMEDIATE ENROLLMENT AVAILABLE
BREAST:
14059 PHASE II TRIAL OF IBRUTINIB PLUS TRASTUZUMAB IN HER2-AMPLIFIED METASTATIC BREAST CANCER SPONSOR- PHARMACYCLICS
PROGRESSION OF DISEASE ON OR WITHIN 6 MONTHS OF COMPLETING PRIOR T-DM1 THERAPY  <4 PRIOR CHEMOTHERAPY REGIMENS FOR MBC (PHASE I PORTION) OR <3 PRIOR CHEMOTHERAPY 20431 PRESERVE-2 PHASE III TRIAL TRIAL OF TRILACICLIB OR PLACEBO IN PATIENTS RECEIVING FIRST- OR SECOND-LINE GEMCITABINE AND CARBOPLATIN CHEMOTHERAPY FOR LOCALLY ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER SPONSOR GI THERAPEUTICS
DOCUMENTATION OF TRIPLE NEGATIVE BREAST CANCER (ESTROGEN AND PROGESTERONE RECEPTOR <1% AND HER2-NEGATIVE). PRIOR SYSTEMIC THERAPIES (COHORT 1 ONLY):
A. NO PRIOR SYSTEMIC THERAPY IN THE LOCALLY ADVANCED UNRESECTABLE/METASTATIC SETTING INCLUDING CHEMOTHERAPY, TARGETED THERAPY, IMMUNOTHERAPY, OR INVESTIGATIONAL AGENTS.
B. PRIOR PD-1/PD-L1 INHIBITOR TREATMENT IS NOT PERMITTED IN ANY SETTING, INCLUDING IN THE NEOADJUVANT SETTING.
C. TIME BETWEEN COMPLETION OF LAST TREATMENT WITH CURATIVE INTENT AND FIRST METASTATIC RECURRENCE MUST BE > 6 MONTHS. PRIOR SYSTEMIC THERAPIES (COHORT 2 ONLY):
A. DOCUMENTATION OF PD-L1 POSITIVE STATUS
B. TREATED WITH A PD-1/PD-L1 INHIBITOR FOR A MINIMUM DURATION OF 4 MONTHS IN THE LOCALLY ADVANCED UNRESECTABLE/METASTATIC SETTING AND AS THE MOST RECENT THERAPY. RADIATION THERAPY FOR METASTATIC DISEASE IS PERMITTED. THERE IS NO REQUIRED MINIMUM WASHOUT PERIOD FOR RADIATION THERAPY. PATIENTS SHOULD BE RECOVERED FROM THE EFFECTS OF RADIATION. ARCHIVAL TUMOR TISSUE MUST BE AVAILABLE OR A FRESH BIOPSY MUST BE OBTAINED, UNLESS APPROVED BY THE MEDICAL MONITOR. EXCLUSION CRITERIA:
PRIOR TREATMENT WITH GEMCITABINE IN ANY SETTING. PRIOR TREATMENT WITH CARBOPLATIN IN THE LOCALLY ADVANCED UNRESECTABLE/METASTATIC SETTING. PRIOR CARBOPLATIN IN THE (NEO)ADJUVANT/CURATIVE SETTING IS PERMITTED AS LONG AS IT WAS COMPLETED > 6 MONTHS PRIOR TO THE FIRST METASTATIC RECURRENCE. PRESENCE OF CENTRAL NERVOUS SYSTEM (CNS) METASTASES AND/OR LEPTOMENINGEAL DISEASE REQUIRING IMMEDIATE TREATMENT WITH RADIATION THERAPY OR STEROIDS. PRIOR HEMATOPOIETIC STEM CELL OR BONE MARROW TRANSPLANTATION.

CLL:
19084 A SINGLE-ARM, EXPANDED ACCESS STUDY OF ZANUBRUTINIB (BGB-3111) IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) MANTLE CELL LYMPHONA (BGB-3111-216)SPONSOR BEIGENE
HISTOLOGICALLY CONFIRMED DIAGNOSIS OF (R/R) MANTLE CELL LYMPHOMA DISEASE OR TREATMENT-NAIVE AND CONSIDERED BY THEIR TREATING PHYSICIAN TO BE UNSUITABLE FOR STANDARD CHEMOIMMUNOTHERAPY REGIMENS  
 
 
 
 
LUNG:
19018 SAPPHIRE A RANDOMIZED PHASE 3 STUDY OF SITRAVATINIB IN COMBINATION WITH NIVOLUMAB VERSUS DOCETAXEL IN PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY AND CHECKPOINT INHIBITOR THERAPY SPONSOR MIRATI
HISTOLOGICALLY CONFIRMED NON-SQUAMOUS NSCLC WITH METASTATIC OR UNRESECTABLE, LOCALLY ADVANCED DISEASE, NOT AMENABLE TO TREATMENT WITH CURATIVE INTENT. RECEIPT OF PRIOR FIRST-LINE TREATMENT IN THE ADVANCED DISEASE SETTING WITH A PLATINUM-BASED CHEMOTHERAPY REGIMEN IN COMBINATION WITH A CIT (I.E., ANTI-PD-1 OR ANTI-PD-L1 INCLUDING NIVOLUMAB, PEMBROLIZUMAB, OR ATEZOLIZUMAB), WITH THE RESULT OF RADIOGRAPHICALLY DOCUMENTED PROGRESSION OF DISEASE ON OR AFTER THE COMBINATION REGIMEN. FIRST-LINE TREATMENT MAY HAVE INCLUDED MAINTENANCE THERAPY WITH A CHEMOTHERAPY AGENT (E.G., PEMETREXED) AND/OR A CIT. DURATION OF TREATMENT ON PRIOR CIT AT LEAST 4 MONTHS. MOST RECENT PRIOR THERAPY (E.G., CHEMOTHERAPY, CIT, OR RADIATION THERAPY) DISCONTINUED AT MINIMUM OF 2 WEEKS BEFORE THE DATE OF FIRST ON-STUDY TREATMENT. CANDIDACY TO RECEIVE TREATMENT WITH DOCETAXEL AS THE NEXT LINE OF THERAPY IF RANDOMIZED TO THE COMPARATOR ARM. 20142  EFFICACY, SAFETY OF TECENTRIQ  COMBINATION WITH CABOMETYX COMPARED WITH DOCETAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER PREVIOUSLY TREATED WITH AN IMMUNE CHECKPOINT INHIBITOR AND PLATINUM-BASED CHEMOTHERAPY SPONSOR GENENTECH
HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED METASTATIC NSCLC DOCUMENTED RADIOGRAPHIC DISEASE PROGRESSION DURING OR FOLLOWING TREATMENT WITH PLATINUM-CONTAINING CHEMOTHERAPY AND ANTI-PD-L1/PD-1 ANTIBODY, ADMINISTERED CONCURRENTLY OR SEQUENTIALLY FOR METASTATIC NSCLC MEASURABLE DISEASE PER RECIST V1.1 OUTSIDE CNS AS ASSESSED BY INVESTIGATOR KNOWN PD-L1 STATUS OR AVAILABILITY OF TUMOR TISSUE FOR CENTRAL PD-L1 TESTING ECOG PERFORMANCE STATUS SCORE OF 0 OR 1

SOLID TUMOR:
20186 TAPISTRY TUMOR-AGNOSTIC PRECISION IMMUNO-ONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU PHASE II PLATFORM-SPONSOR ROCHE
COHORT BIOMARKER STUDY TREATMENT PROJECTED ENROLLMENT: COHORT A ROS1 FUSION-POSITIVE TUMORS ENTRECTINIB 50 3ROS1 fusion with protein coding 5’gene fusion partner(EXCLUDING ROS1point  mutations)
COHORT B NTRK1/2/3 FUSION-POSITIVE TUMORS ENTRECTINIB 200 3’ NTRK1/2/3 fusion with protein coding 5’gene fusion partner (EXCLUDING NTRK 1/2/3 point mutations)
COHORT C ALK FUSION-POSITIVE TUMORS ALECTINIB 50 3’ALK fusion with a protein coding 5’gene fusion partner(EXCLUDING ALK point mutations)
COHORT D TMB-HIGH > or = 16Mutations per megabase TUMORS ATEZOLIZUMAB 150 COHORT E AKT1/2/3 MUTANT-POSITIVE TUMORS IPATASERTIB 50 AKT1 and AKT3: E17K;L52R;Q79K
AKT2: E17K
COHORT F HER2 MUTANT-POSITIVE TUMORS TRASTUZUMAB EMTANSINE 50 (EXCLUDING HER2GENE APMPLIFICATION) Furin Domain-G222C;R226S;E265K;D277H;G292R;G309A/E;S310F/Y;C311R/S;E321G;C334S

Transmembrane domain: S653C;V659E;G660D;R678Q
GFR domain IV: P551L;R552S
Receptor L: S418T;A440T
COHORT H PIK3CA MULTIPLE MUTANT(> or =2)-POSITIVE TUMORS  INAVOLISIB TOTAL 650 One mutation must be E542A/K/Q/V,E545A/D/K/G OR H1047R/LY
UROTHELIAL:
20172 PHASE 2 TRIAL OF ENORTUMAB VEDOTIN AS MONOTHERAPY OR IN COMBINATION WITH ANTICANCER THERAPIES FOR THE TREATMENT OF UROTHELIAL CANCER (SGN22E-002)SPONSOR SEATTLE GENETICS
RANDOMIZED COHORT K: ENFORTUMAB VEDOTIN + PEMBROLIZUMAB-ENFORTUMAB VEDOTIN ON DAYS 1 AND 8 PLUS PEMBROLIZUMAB ON DAY 1 EVERY 21 DAY FOR CISPLATIN INELIGIBLE  
OPEN DATA TRIALS-IMMEDIATE ENROLLMENT AVAILABLE :

BREAST:
17079 MAMMAPRINT, BLUEPRINT, AND FULL-GENOME DATA LINKED WITH CLINICAL DATA TO EVALUATE NEW GENE EXPRESSION PROFILES: AN ADAPTABLE REGISTRY (FLEX REGISTRY)
NEW BREAST CANCER DIAGNOSIS PROSTATE:
19144 METASTATIC PROSTATE FOR OUR BIOMARKER DATA TRIAL – NO DRUG- DATA TRIAL- LOOKING FOR GENE MUTATIONS IN PROSTATE
UROTHELIAL:
19032BIOMARKER STUDY TO IDENTIFY SUBJECTS WITH ADVANCED UROTHELIAL CANCER AND FIBROBLAST GROWTH FACTOR RECEPTOR GENE ABERRATIONS (42756493BLC0002)
TRANSITIONAL CELL CARCINOMA OF THE UROTHELIUM. MINOR COMPONENTS (LESS THAN [<] 50 PERCENT OVERALL) OF VARIANT HISTOLOGY ARE ACCEPTABLE. DIAGNOSIS OF EITHER: A.) METASTATIC OR SURGICALLY UNRESECTABLE UROTHELIAL CANCER (UC) (STAGE IV), B.) LOCALIZED SURGICALLY-RESECTABLE OR RESECTED UC WITH A T CLASSIFICATION OF T2 OR ABOVE WHO ARE AT HIGH RISK FOR PROGRESSION TO ADVANCED DISEASE AS ASSESSED BY THE INVESTIGATOR. AVAILABLE ARCHIVAL TISSUE SAMPLE FOR FIBROBLAST GROWTH FACTOR RECEPTOR (FGFR) ABERRATION ANALYSIS. THE ARCHIVED TISSUE MUST EITHER BE FROM 1) METASTATIC SITE, 2) LOCALIZED UC SPECIMEN THAT INCLUDES MUSCLE INVASIVE DISEASE (T2 OR ABOVE). EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS OF 0 TO 2.  
STAR TRIALS: 3-4 WEEKS FOR ENROLLMENT
 
18264 BILIARY, GALL BLADDER:
18264 PROOF TRIAL A PHASE 3 MULTICENTER, OPEN-LABEL, RANDOMIZED, CONTROLLED STUDY OF ORAL INFIGRATINIB VERSUS GEMCITABINE WITH CISPLATIN IN SUBJECTS WITH ADVANCED/METASTATIC OR INOPERABLE CHOLANGIOCARCINOMA WITH FGFR2 GENE FUSIONS/TRANSLOCATIONS: (QBGJ398-301)SPONSOR QED THERAPEUTICS
HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED NON-RESECTABLE, RECURRENT OR METASTATIC CHOLANGIOCARCINOMA. PARTICIPANTS WITH GALLBLADDER CANCER OR AMPULLA OF VATER CARCINOMA ARE NOT ELIGIBLE. MUST NOT HAVE RECEIVED TREATMENT WITH ANY SYSTEMIC ANTI-CANCER THERAPY FOR UNRESECTABLE, RECURRENT, OR METASTATIC CHOLANGIOCARCINOMA. PRIOR NEOADJUVANT OR ADJUVANT THERAPY IS PERMITTED IF COMPLETED > 6 MONTHS PRIOR TO FIRST DOSE OF STUDY DRUG.  

ANAL:
20189 A PHASE 3 GLOBAL, MULTICENTER, DOUBLE-BLIND RANDOMIZED STUDY OF CARBOPLATIN-PACLITAXEL WITH INCMGA00012 OR PLACEBO IN PARTICIPANTS WITH INOPERABLE LOCALLY RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE ANAL CANAL NOT PREVIOUSLY TREATED WITH SYSTEMIC CHEMOTHERAPY (POD1UM-303/INTERAACT 2) (INCMGA 0012-303) SPONSOR IQVIA
HISTOLOGICALLY OR CYTOLOGICALLY VERIFIED, INOPERABLE LOCALLY RECURRENT OR METASTATIC SCAC. NO PRIOR SYSTEMIC THERAPY OTHER THAN THE FOLLOWING: A. CHEMOTHERAPY ADMINISTERED CONCOMITANTLY WITH RADIOTHERAPY AS A RADIOSENSITIZING AGENT IS PERMITTED. PRIOR NEOADJUVANT OR ADJUVANT THERAPY IF COMPLETED > 6 MONTHS BEFORE STUDY ENTRY BREAST:
19054 RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF TUCATINIB OR PLACEBO IN COMBINATION WITH ADO-TRASTUZUMAB EMTANSINE (T-DM1) FOR SUBJECTS WITH UNRESECTABLE LOCALLY-ADVANCED OR METASTATIC HER2+ BREAST CANCER (HER2CLIMB-02) (SGNTUC-016)SPONSOR: SEATTLE GENETICS
HISTOLOGICALLY CONFIRMED HER2+ METASTATIC BREAST CARCINOMA AS DETERMINED BY A SPONSOR-DESIGNATED CENTRAL LABORATORY  HISTORY OF PRIOR TREATMENT WITH A TAXANE AND TRASTUZUMAB IN ANY SETTING, SEPARATELY OR IN COMBINATION HAVE PROGRESSION OF UNRESECTABLE LA/M BREAST CANCER AFTER LAST SYSTEMIC THERAPY, OR BE INTOLERANT OF LAST SYSTEMIC THERAPY

CERVICAL:
20225 A PHASE 2, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AK104 IN SUBJECTS WITH RECURRENT OR METASTATIC CERVICAL CANCER (AK104-201-AU)SPONSOR: PPD
SUBJECTS MUST HAVE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED RECURRENT OR METASTATIC SQUAMOUS CARCINOMA OR ADENOSQUAMOUS CARCINOMA OF THE CERVIX, HAVE THE FOLLOWING CRITERIA: DISEASE PROGRESSION CONFIRMED BY RADIOLOGIC IMAGING DURING OR FOLLOWING PRIOR PLATINUM BASED DOUBLET CHEMOTHERAPY, WITH OR WITHOUT BEVACIZUMAB FOR RECURRENT OR METASTATIC CERVICAL CANCER; NO MORE THAN 2 PRIOR SYSTEMIC THERAPIES IN THE RECURRENT OR METASTATIC SETTING. AVAILABLE ARCHIVED TUMOR TISSUE SAMPLE - BLOCK OR A MINIMUM OF 10 UNSTAINED SLIDES OF FORMALIN FIXED PARAFFIN EMBEDDED [FFPE] TISSUES - PREFERABLY FROM THE MOST RECENT BIOPSY OF A TUMOR LESION COLLECTED EITHER AT THE TIME OF OR AFTER THE DIAGNOSIS OF LOCALLY ADVANCED, RECURRENT, AND/OR METASTATIC DISEASE HAS BEEN MADE.

COLON/RECTAL:
20216 MOUNTAINEER: A PHASE 2, OPEN LABEL STUDY OF TUCATINIB COMBINED WITH TRASTUZUMAB IN PATIENTS WITH HER2+ METASTATIC COLORECTAL CANCER (ACCRU-GI-1617, SGNTUC-017) SPONSOR: SEATTLE GENETICS
HISTOLOGICALLY AND/OR CYTOLOGICALLY DOCUMENTED ADENOCARCINOMA OF THE COLON OR RECTUM THAT IS METASTATIC AND/OR UNRESECTABLE UNLESS CONTRAINDICATED, PARTICIPANTS MUST HAVE RECEIVED AND FAILED REGIMENS CONTAINING THE FOLLOWING AGENTS: FLUOROPYRIMIDINE (E.G., 5-FLUOROURACIL OR CAPECITABINE), OXALIPLATIN, IRINOTECAN, AN ANTI-VEGF MONOCLONAL ANTIBODY (BEVACIZUMAB, RAMUCIRUMAB, OR ZIV-AFLIBERCEPT), AND AN ANTI-PD-(L)1 THERAPY (NIVOLUMAB OR PEMBROLIZUMAB) IF TUMOR HAS DEFICIENT MISMATCH REPAIR PROTEINS OR IS MSI-HIGH. HAVE PROGRESSION OF UNRESECTABLE OR METASTATIC CRC AFTER THE LAST SYSTEMIC THERAPY, OR BE INTOLERANT OF LAST SYSTEMIC THERAPY HAVE RAS WILD-TYPE IN PRIMARY OR METASTATIC TUMOR TISSUE, BASED ON EXPANDED RAS TESTING WILLING AND ABLE TO PROVIDE THE MOST RECENT TISSUE BLOCKS OBTAINED PRIOR TO TREATMENT INITIATION. IF ARCHIVAL TISSUE IS NOT AVAILABLE, THEN A NEWLY-OBTAINED BASELINE BIOPSY OF AN ACCESSIBLE TUMOR HAVE CONFIRMED HER2-POSITIVE MCRC, AS DEFINED BY HAVING TUMOR TISSUE TESTED AT A CLINICAL LABORATORY IMPROVEMENT ACT (CLIA)-CERTIFIED LABORATORY, MEETING AT LEAST ONE OF THE FOLLOWING CRITERIA: HER2+ OVEREXPRESSION (3+ IMMUNOHISTOCHEMISTRY [IHC])BY AN FDA-APPROVED HER2 ICH TEST HER2 2+ IHC IS ELIGIBLE IF THE TUMOR IS AMPLIFIED BY AN FDA-APPROVED HER2 IN SITU HYBRIDIZATION ASSAY (FISH OR CHROMOGENIC IN SITU HYBRIDIZATION [CISH])) HER2 (ERBB2) AMPLIFICATION BY CLIA-CERTIFIED NEXT GENERATION SEQUENCING (NGS) SEQUENCING ASSAY

ESOPHAGEAL:
20171 A MULTICENTER, DOUBLE-BLIND, RANDOMIZED PHASE III CLINICAL TRIAL EVALUATING THE EFFICACY AND SAFETY OF SINTILIMAB VS. PLACEBO, IN COMBINATION WITH CHEMOTHERAPY, FOR FIRST-LINE TREATMENT OF UNRESECTABLE, LOCALLY ADVANCED, RECURRENT, OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ORIENT-15)CIBI308A301SPONSOR: COVANCE
HISTOPATHOLOGICALLY CONFIRMED UNRESECTABLE, LOCALLY ADVANCED, RECURRENT OR METASTATIC ESCC (EXCLUDING MIXED ADENOSQUAMOUS CARCINOMA AND OTHER HISTOLOGICAL SUBTYPES) ECOG PS OF 0 OR 1 SUBJECT MUST BE UNSUITABLE FOR DEFINITIVE TREATMENT, SUCH AS DEFINITIVE CHEMORADIOTHERAPY AND/OR SURGERY. FOR SUBJECTS WHO HAVE RECEIVED (NEO)ADJUVANT OR DEFINITIVE CHEMOTHERAPY/RADIOCHEMOTHERAPY, TIME FROM THE COMPLETION OF LAST TREATMENT TO DISEASE RECURRENCE MUST BE > 6 MONTHS COULD PROVIDE ARCHIVAL OR FRESH TISSUES FOR PD-L1 EXPRESSION ANALYSIS WITH OBTAINABLE RESULTS ESSENTIAL THROMBOCYTHEMIA,

MYELOFIBROSIS:
19171 A RANDOMIZED, CONTROLLED PHASE 3 STUDY OF PACRITINIB VERSUS PHYSICIAN'S CHOICE IN PATIENTS WITH PRIMARY MYELOFIBROSIS, POST POLYCYTHEMIA VERA MYELOFIBROSIS, OR POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS WITH SEVERE THROMBOCYTOPENIA (PLATELETS COUNTS <50,000/µL) (PAC203) SPONSOR: CTI BioPharma
PMF, PPV-MF, OR PET-MF (AS DEFINED BY TEFFERI AND VARDIMAN 2008) DIPSS INTERMEDIATE-1, INTERMEDIATE -2, OR HIGH RISK (PASSAMONTI ET AL 2010)  PRIOR RUXOLITINIB TREATMENT WITH FAILURE TO BENEFIT OR INTOLERANCE AS DEFINED BY AT LEAST ONE OF THE FOLLOWING: TREATMENT FOR ≥3 MONTHS WITH INADEQUATE EFFICACY RESPONSE DEFINED AS <10% SPLEEN VOLUME REDUCTION BY MRI OR <30% DECREASE FROM BASELINE IN SPLEEN LENGTH BY PHYSICAL EXAMINATION OR REGROWTH TO THESE PARAMETERS FOLLOWING AN INITIAL RESPONSE; AND/OR TREATMENT FOR ≥28 DAYS COMPLICATED BY EITHER: DEVELOPMENT OF A RED BLOOD CELL TRANSFUSION REQUIREMENT (AT LEAST 2 UNITS/MONTH FOR 2 MONTHS) OR NATIONAL CANCER INSTITUTE (NCI) CTCAE GRADE ≥3 AES OF THROMBOCYTOPENIA, ANEMIA, HEMATOMA, AND/OR HEMORRHAGE WHILE BEING TREATED WITH A DOSAGE OF <20 MG BID PALPABLE SPLENOMEGALY ≥5 CM BELOW THE LOWER COSTAL MARGIN IN THE MIDCLAVICULAR LINE AS ASSESSED BY PHYSICAL EXAMINATION 20177 M16-191: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF NAVITOCLAX IN COMBINATION WITH RUXOLITINIB VERSUS RUXOLITINIB IN SUBJECTS WITH MYELOFIBROSIS (TRANSFORM-1) SPONSOR: ABBVIE
DOCUMENTED DIAGNOSIS OF PRIMARY MYELOFIBROSIS (MF) OR SECONDARY MF (POST POLYCYTHEMIA VERA [PPV] - MF OR POST ESSENTIAL THROMBOCYTOPENIA [PET] - MF) AS DEFINED BY WORLD HEALTH ORGANIZATION (WHO) CLASSIFICATION. MUST BE ABLE TO COMPLETE THE MF SYMPTOM ASSESSMENT FORM (MFSAF) V4.0 ON AT LEAST 4 OUT OF 7 DAYS PRIOR TO RANDOMIZATION. (*MUST HAVE AT LEAST 2 SYMPTOMS WITH A SCORE >=3 OR A TOTAL SCORE OF >=12, AS MEASURED BY THE MFSAF V4.0.) CLASSIFIED AS INTERMEDIATE-2, OR HIGH-RISK MF AS DEFINED BY THE DYNAMIC INTERNATIONAL PROGNOSTIC SCORING SYSTEM PLUS (DIPSS+). HAS SPLENOMEGALY DEFINED AS SPLEEN PALPATION MEASUREMENT >= 5 CENTIMETERS (CM) BELOW COSTAL MARGIN OR SPLEEN VOLUME GREATER THAN OR EQUAL TO 450 CUBIC CM AS ASSESSED CENTRALLY BY MAGNETIC RESONANCE IMAGING (MRI) OR COMPUTED TOMOGRAPHY (CT) SCAN. EXCLUSION CRITERIA: PRIOR TREATMENT WITH A JANUS KINASE-2 (JAK-2) INHIBITOR. PRIOR TREATMENT WITH A BH3-MIMETIC COMPOUND OR BROMODOMAIN AND EXTRA-TERMINAL MOTIF (BET) INHIBITOR. RECEIVING MEDICATION THAT INTERFERES WITH COAGULATION OR PLATELET FUNCTION EXCEPT FOR LOW DOSE ASPIRIN (UP TO 100 MILLIGRAM DAILY) AND LOW MOLECULAR WEIGHT HEPARIN (LMWH) WITHIN 3 DAYS PRIOR TO THE FIRST DOSE OF STUDY DRUG OR DURING THE STUDY TREATMENT PERIOD.

LUNG:
20269A RANDOMIZED PHASE 3 STUDY OF MRTX849 VERSUS DOCETAXEL IN PATIENTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER WITH KRAS G12C MUTATION (849-012)SPONSOR: MIRATI
INCLUSION CRITERIA:
HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED DIAGNOSIS OF NSCLC WITH KRAS G12C MUTATION. CANDIDACY TO RECEIVE TREATMENT WITH DOCETAXEL. EXCLUSION CRITERIA:
PRIOR TREATMENT WITH AN AGENT TARGETING KRAS G12C (E.G., AMG 510). ACTIVE BRAIN METASTASES. 20331 A PHASE 2 STUDY OF VS-6766 (DUAL RAF/MEK INHIBITOR) AS A SINGLE AGENT AND IN COMBINATION WITH DEFACTINIB (FAK INHIBITOR) IN RECURRENT KRAS-MUTANT (KRAS-MT) NON-SMALL CELL LUNG CANCER (NSCLC)(VS-6766-202) SPONSOR VERASTEM
INCLUSION CRITERIA:
KNOWN KRAS MUTATION AN EASTERN COOPERATIVE GROUP (ECOG) PERFORMANCE STATUS < 1
EXCLUSION CRITERIA HISTORY OF PRIOR MALIGNANCY, WITH THE EXCEPTION OF CURATIVELY TREATED MALIGNANCIES HISTORY OF TREATMENT WITH A DIRECT AND SPECIFIC INHIBITOR OF MEK OR KRAS SYMPTOMATIC BRAIN METASTASES REQUIRING STEROIDS OR OTHER LOCAL INTERVENTIONS. 20250 MARIPOSA A PHASE III STUDY OF AMIVANTAMAB AND LAZERTINIB COMBINATION THERAPY VS OSIMERINIB VS LAZERTINIB AS FIRST LINE TREATMENT IN PATIENTS WITH EGFR LOCALLY ADVANCED OR METATATIC NON SMALL CELL LUNG CANCER SPONSOR: JANSSEN
PARTICIPANT MUST HAVE A TUMOR THAT WAS PREVIOUSLY DETERMNED TO HAVE EXON 19 DELETIONS (Exon19del) or Exon 21L858R SUBSTITUTION 20249A RANDOMIZED, OPEN-LABEL PHASE 3 STUDY OF COMBINATION AMIVANTAMAB AND CARBOPLATIN-PEMETREXED THERAPY, COMPARED WITH CARBOPLATIN-PEMETREXED, IN PATIENTS WITH EGFR EXON 20INS MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (61186372NSC3001) SPONSOR JANSEEN
PARTICIPANT MUST HAVE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED, LOCALLY ADVANCED OR METASTATIC, NONSQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) WITH DOCUMENTED PRIMARY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20INS ACTIVATING MUTATION PARTICIPANT MUST HAVE MEASURABLE DISEASE ACCORDING TO RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) V1.1. PARTICIPANT MUST HAVE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS 0 OR 1  PARTICIPANT MUST AGREE TO GENETIC CHARACTERIZATION OF TUMOR STATUS THROUGH THE REQUIRED PRETREATMENT TUMOR BIOPSY (OR SUBMISSION OF EQUIVALENT ARCHIVAL MATERIAL), AS WELL AS BASELINE AND PERIODIC BLOOD SAMPLES FOR ANALYSIS OF TUMOR MUTATIONS IN THE BLOODSTREAM 18129 BRIGATINIB-3001- A PHASE 3 RANDOMIZED OPEN-LABEL STUDY OF BRIGATINIB (ALUNBRIG®) VERSUS ALECTINIB (ALECENSA®) IN ADVANCED ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON–SMALL-CELL LUNG CANCER PATIENTS WHO HAVE PROGRESSED ON CRIZOTINIB (XALKORI®) -ALK+
SPONSOR: PRA HEALTH SCIENCES
HAVE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED STAGE IIIB (LOCALLY ADVANCED OR RECURRENT) OR STAGE IV NON-SMALL CELL LUNG CANCER (NSCLC). MUST MEET ONE OF THE FOLLOWING CRITERIA: *HAVE DOCUMENTATION OF ANAPLASTIC LYMPHOMA KINASE (ALK) REARRANGEMENT BY A POSITIVE RESULT FROM THE VYSIS ALK BREAK-APART FLUORESCENCE IN SITU HYBRIDIZATION (FISH) PROBE KIT OR THE VENTANA ALK (D5F3) CDX ASSAY OR FOUNDATION MEDICINE'S FOUNDATION ONE CDX. *HAVE DOCUMENTED ALK REARRANGEMENT BY A DIFFERENT TEST AND BE ABLE TO PROVIDE TUMOR SAMPLE TO THE CENTRAL LABORATORY. (NOTE: CENTRAL LABORATORY ALK REARRANGEMENT TESTING RESULTS ARE NOT REQUIRED TO BE OBTAINED BEFORE RANDOMIZATION). HAD PROGRESSIVE DISEASE (PD) WHILE ON CRIZOTINIB, AS ASSESSED BY THE INVESTIGATOR OR TREATING PHYSICIAN. (NOTE: CRIZOTINIB DOES NOT NEED TO BE THE LAST THERAPY A PARTICIPANT RECEIVED. THE PARTICIPANT MAY HAVE RECEIVED CHEMOTHERAPY AS HIS/HER LAST THERAPY). 19208 A RANDOMIZED, OPEN-LABEL, PHASE 3 STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR FIRST LINE TREATMENT OF RET FUSION-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER (BLU-667-2303) SPONSOR:COVANCE
PATIENT HAS PATHOLOGICALLY CONFIRMED, DEFINITIVELY DIAGNOSED, ADVANCED (NOT ABLE TO BE TREATED WITH SURGERY OR RADIOTHERAPY) OR METASTATIC NSCLC AND HAS NOT BEEN TREATED WITH SYSTEMIC ANTICANCER THERAPY FOR METASTATIC DISEASE. PATIENT MUST HAVE A DOCUMENTED RET-FUSION  
19239:KEEPSAKE DOUBLE BLIND STUDY OF THE GLUTAMINASE INHIBITOR TELAGLENASTAT WITH PEMBROLIZUAB AND CHEMOTHERAPY VESUS PLACEBO WITH PEMBROLIZUMAB AND CHEMOTHERAPY IN FIRST LINE METASTATIC KEAP1/NRF2 MUTATED NONSQUAMOUS, NONSMALL CELL LUNG CANCER SPONSOR: CX-839-014
 
STAGE IV DISEASE NOT PREVIOUSLY TREATED WITH SYSTEMIC THERAPY FOR METASTTIC NSCLC. PATIENTS WHO RECEIVED ADJUVANT OR NEOADJUVANT THERAPY WITH OR WITHOUT IMMUNOTHERAPY FOR LOCALIZED NSCLC ARE ELIGIBLE IF ALL ADJUVANT/NEOADJUVANT THERAPY IINCLUDING IMMUNOTHERAPY) WAS COMPLETED AT LEAST 6 MONTHS PRIOR TO THE DEVELOPMENT OF METASTATIC DISEASE MUTATION KEAP1OR NRF2 DOCUMENTED BY NGS AND STK11/LKB1 MUTATION IS KNOWN FOR THE PURPOSE OF STRATIFICATION  
LYMPHOMA: HODGKINS AND NON HODGKINS:
11282 (SGN35-015) A PHASE 2 OPEN-LABEL STUDY OF BRENTUXIMAB VEDOTIN IN FRONT-LINE THERAPY OF HODGKIN LYMPHOMA (HL) AND CD30-EXPRESSING PERIPHERAL T-CELL LYMPHOMA (PTCL) IN OLDER PATIENTS OR PATIENTS WITH SIGNIFICANT COMORBIDITIES INELIGIBLE FOR STANDARD CHEMOTHERAPY SPONSOR: SEATTLE GENETICS
TREATMENT-NAIVE PATIENTS WITH HISTOPATHOLOGICAL DIAGNOSIS OF CLASSICAL HODGKIN LYMPHOM TREATMENT-NAIVE PATIENTS WITH CD30-EXPRESSING

HODGKIN’S:
18013 SGN35-027: MULTIPLE PART CLINICAL TRIAL OF BRENTUXIMAB VEDOTIN (INCLUDING NIVOLUMAB) IN CLASSICAL HODGKIN LYMPHOMA SUBJECTSPONSOR: SEATTLE GENETICS
TREATMENT-NAÏVE, HODGKIN LYMPHOMA (HL) PATIENTS WITH ANN ARBOR STAGE 3 OR 4 DISEASE

​MERKEL CELL:
17144MERKEL CELL CARCINOMA, CUTANEOUS SQUAMOUS CELL CARCINOMA, OR OTHER ADVANCED SOLID TUMORS: A PHASE 1B/2 STUDY OF CAVROTOLIMOD COMBINED WITH PEMBROLIZUMAB OR CEMIPLIMAB (AST-008-102) SPONSOR: AST-008 102
PHASE 2 MCC EXPANSION COHORT: LOCALLY ADVANCED OR METASTATIC MERKEL CELL CARICINOMA PHASE 2 CSCC EXPANSION COHORT: LOCALLY ADVANCED OR METASTATIC CUTANEOUS SQUAMOUS CELL CARCINOMA PHASE 2 EXPLORATORY EXPANSION COHORT: LOCALLY ADVANCED OR METASTATIC MERKEL CELL CARCINOMA OR ADVANCED OR METASTATIC MELANOMA AGREES TO PROVIDE A NEWLY OBTAINED BIOPSY OF TWO LESIONS  

OVARIAN:
20298 A PHASE 2 STUDY OF VS-6766 (DUAL RAF/MEK INHIBITOR) ALONE AND IN COMBINATION WITH DEFACTINIB (FAK INHIBITOR) IN RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC)(VS-6766-201) (GOG 3052) SPONSOR VERASTEM
HISTOLOGICALLY PROVEN LGSOC (OVARIAN, PERITONEAL)  IN PART A KRAS MUTATION PROGRESSION OR RECURRENCE OF LGSOC AFTER AT LEAST ONE PRIOR SYSTEMIC THERAPY FOR METASTATIC DISEASE. PROSTATE:
16238 TRITON3: A MULTICENTER, RANDOMIZED, OPEN-LABEL PHASE 3 STUDY OF RUCAPARIB VERSUS PHYSICIAN'S CHOICE OF THERAPY FOR PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (CO-338-063)
SPONSOR: CLOVIS
EXPERIENCED DISEASE PROGRESSION AFTER HAVING RECEIVED 1 PRIOR NEXT GENERATION ANDROGEN RECEPTOR-TARGETED THERAPY FOR CASTRATION-RESISTANT DISEASE HAVE A DELETERIOUS MUTATION IN A BRCA1/2 OR ATM GENE NO PRIOR TREATMENT WITH ANY PARP INHIBITOR NO PRIOR TREATMENT WITH CHEMOTHERAPY FOR MCRPC. 18103 A PHASE 3 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF NIRAPARIB IN COMBINATION WITH ABIRATERONE ACETATE AND PREDNISONE VERSUS ABIRATERONE ACETATE AND PREDNISONE FOR TREATMENT OF SUBJECTS WITH METASTATIC PROSTATE CANCER (64091742PCR3001)SPONSOR: SEATTLE GENETICS
NO SYSTEMIC THERAPY (THAT IS, NOVEL SECOND-GENERATION AR-TARGETED THERAPY SUCH AS ENZALUTAMIDE, APALUTAMIDE, OR DAROLUTAMIDE; TAXANE-BASED CHEMOTHERAPY, OR MORE THAN 4 MONTHS OF ABIRATERONE ACETATE PLUS PREDNISONE [AA-P] PRIOR TO RANDOMIZATION) IN THE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) SETTING; OR AA-P OUTSIDE OF THE MCRPC SETTING 20248 A PHASE 3 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF NIRAPARIB IN COMBINATION WITH ABIRATERONE ACETATE AND PREDNISONE VERSUS ABIRATERONE ACETATE AND PREDNISONE FOR THE TREATMENT OF PARTICIPANTS WITH DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)(67652000PCR3002) SPONSOR: JANSEEN
DIAGNOSIS OF PROSTATE ADENOCARCINOMA  WILLING TO PROVIDE AN ARCHIVAL TUMOR TISSUE SAMPLE OR A FRESH TUMOR TISSUE SAMPLE. IF GERMLINE POSITIVE FOR DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE MUTATIONS, AN ARCHIVED OR FRESH TUMOR TISSUE SAMPLE IS NOT REQUIRED METASTATIC DISEASE DOCUMENTED BY GREATER THAN OR EQUAL TO (>=) 1 BONE LESION(S) ON TECHNETIUM-99M (99MTC) BONE SCAN. PARTICIPANTS WITH A SINGLE BONE LESION MUST HAVE CONFIRMATION OF BONE METASTASIS BY COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) ANDROGEN DEPRIVATION THERAPY (EITHER MEDICAL OR SURGICAL CASTRATION) MUST HAVE BEEN STARTED >=14 DAYS PRIOR TO RANDOMIZATION AND WILLING TO CONTINUE THROUGH THE TREATMENT PHASE. PARTICIPANTS WHO START A GONADOTROPIN-RELEASING HORMONE (GNRH) AGONIST LESS THAN OR EQUAL TO (<=) 28 DAYS PRIOR TO RANDOMIZATION WILL BE REQUIRED TO TAKE A FIRST-GENERATION ANTI-ANDROGEN FOR >=14 DAYS PRIOR TO RANDOMIZATION. THE ANTI-ANDROGEN MUST BE DISCONTINUED PRIOR TO RANDOMIZATION OTHER ALLOWED PRIOR THERAPY FOR METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC): (A) MAXIMUM OF 1 COURSE OF RADIATION OR SURGICAL INTERVENTION TO MANAGE SYMPTOMS OF PROSTATE CANCER. RADIATION WITH CURATIVE INTENT IS NOT ALLOWED. RADIATION MUST BE COMPLETED PRIOR TO RANDOMIZATION (B) <= 6 MONTHS OF ANDROGEN DEPRIVATION THERAPY (ADT) PRIOR TO RANDOMIZATION; AND (C) 30 DAYS OF ABIRATERONE ACETATE + PREDNISONE (AA-P) ALLOWED IF REQUIRED

SKIN:
18014 PHASE I OPEN LABEL TREATMENT DURATION INCREMENT EXPANSION, SAFETY, AND PHARMOCODYNAMIC STUDY OF CX-4945 ADMINISTERED ORALLY TWICE DAILY TO PATIENTS WITH ADVANCED BASAL CELL CARCINOMASPONSOR: SENHWA BIOSCIENCES

SOLID TUMORS:
19079 (INCB 54828-207) A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEMIGATINIB IN PARTICIPANTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED/METASTATIC OR SURGICALLY UNRESECTABLE SOLID TUMOR MALIGNANCIES HARBORING ACTIVATING FGFR MUTATIONS OR TRANSLOCATIONS (FIGHT-207)SPONSOR: INCYTE
HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED SOLID TUMOR MALIGNANCY THAT IS ADVANCED OR METASTATIC OR IS SURGICALLY UNRESECTABLE. RADIOGRAPHICALLY MEASURABLE DISEASE (PER RECIST V1.1 OR RANO FOR PRIMARY BRAIN TUMORS). TUMOR LESIONS LOCATED IN A PREVIOUSLY IRRADIATED AREA OR IN AN AREA SUBJECTED TO OTHER LOCO-REGIONAL THERAPY ARE CONSIDERED MEASURABLE IF PROGRESSION HAS BEEN CLEARLY DEMONSTRATED IN THE LESION. DOCUMENTATION OF AN FGFR1-3 GENE MUTATION OR TRANSLOCATION. OBJECTIVE PROGRESSION AFTER AT LEAST 1 PRIOR THERAPY AND NO THERAPY AVAILABLE THAT IS LIKELY TO PROVIDE CLINICAL BENEFIT. PARTICIPANTS WHO ARE INTOLERANT TO OR DECLINE THE APPROVED THERAPY ARE ELIGIBLE ONLY IF THEY HAVE NO THERAPY AVAILABLE THAT IS LIKELY TO PROVIDE CLINICAL BENEFIT. 20245 CRESTONE PHASE 2 STUDY OF SERIBANTUMAB IN ADULT PATIENTS WITH  NRG1 FUSIONPOSIIVE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS SPONSOR : ELAVATION ONCOLOGY
LOCALLY ADVANCED OR METASTATIC SOLID TUMOR WITH AN NRG1 GENE FUSION IDENTIFIED THROUGH MOLECULAR ASSAYS, SUCH AS PCR, NGS (RNA OR DNA) OR FISH, BY A CLIA-CERTIFIED OR SIMILARLY ACCREDITED LABORATORY AVAILABILITY OF FRESH OR ARCHIVED FFPE TUMOR SAMPLE TO BE SUBMITTED TO A CENTRAL LABORATORY FOR CONFIRMATION OF NRG1 GENE FUSION STATUS PATIENTS SHOULD HAVE RECEIVED A MINIMUM OF ONE PRIOR STANDARD THERAPY APPROPRIATE FOR THEIR TUMOR TYPE AND STAGE OF DISEASE, PROGRESSED OR BEEN NONRESPONSIVE TO THESE AVAILABLE THERAPIES, WITH NO FURTHER AVAILABLE CURATIVE THERAPY OPTIONS ECOG PERFORMANCE STATUS (PS) 0, 1 OR 2 20344A PHASE 2 BASKET STUDY OF TUCATINIB IN COMBINATION WITH TRASTUZUMAB IN SUBJECTS WITH PREVIOUSLY TREATED, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC SOLID TUMORS DRIVEN BY HER2 ALTERATIONS (SGNTUC-019) SPONSOR: SEATTLE GENETICS
HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED DIAGNOSIS OF LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC SOLID TUMOR, INCLUDING PRIMARY BRAIN TUMORS PARTICIPANTS WITH DISEASE TYPES OTHER THAN BREAST CANCER, BILIARY TRACT CANCER, NON-SQUAMOUS NSCLC, AND CERVICAL CANCER: DISEASE PROGRESSION ON OR AFTER THE MOST RECENT SYSTEMIC THERAPY FOR LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC DISEASE PARTICIPANTS WITH ANY BREAST CANCER SUBTYPE: MUST HAVE HER2-MUTATED DISEASE WHICH DOES NOT DISPLAY HER2 OVEREXPRESSION/AMPLIFICATION MUST HAVE PROGRESSED ON OR AFTER >1 PRIOR LINE OF TREATMENT (CHEMOTHERAPY, ENDOCRINE THERAPY, OR TARGETED THERAPY) FOR LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC BREAST CANCER PARTICIPANTS WITH METASTATIC HR+ HER2-MUTATED DISEASE MUST HAVE RECEIVED A PRIOR CDK4/6 INHIBITOR IN THE METASTATIC SETTING PARTICIPANTS WITH BILIARY TRACT CANCER: MUST HAVE COMPLETED >1 PRIOR LINE OF TREATMENT (CHEMOTHERAPY, ENDOCRINE THERAPY, OR TARGETED THERAPY) PARTICIPANTS WITH NON-SQUAMOUS NSCLC: HAS RELAPSED FROM OR IS REFRACTORY TO STANDARD TREATMENT OR FOR WHICH NO STANDARD TREATMENT IS AVAILABLE PARTICIPANTS WITH CERVICAL CANCER: PARTICIPANTS WITH METASTATIC CERVICAL CANCER MUST HAVE PROGRESSED ON OR AFTER >1 PRIOR LINE OF SYSTEMIC THERAPY IN THE METASTATIC SETTING. PARTICIPANTS WITH LOCALLY ADVANCED UNRESECTABLE CERVICAL CANCER MUST HAVE PROGRESSED ON OR AFTER >1 PRIOR LINES OF SYSTEMIC THERAPY.  
 
 
19092 A PHASE 2 STUDY OF ERDAFITINIB IN SUBJECTS WITH ADVANCED SOLID TUMORS AND FGFR GENE ALTERATIONS (42756493CAN2002)SPONSOR JANSEEN
HISTOLOGIC DEMONSTRATION OF AN UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC SOLID TUMOR MALIGNANCY WITH A FIBROBLAST GROWTH FACTOR RECEPTOR (FGFR) MUTATION OR FGFR GENE FUSION MEASURABLE DISEASE PARTICIPANT MUST HAVE RECEIVED AT LEAST ONE PRIOR LINE OF SYSTEMIC THERAPY IN THE METASTATIC SETTING DOCUMENTED PROGRESSION OF DISEASE, DEFINED AS ANY PROGRESSION THAT REQUIRES A CHANGE IN TREATMENT, PRIOR TO FULL STUDY SCREENING 18164 A PHASE 1/2 STUDY OF THE HIGHLY-SELECTIVE RET INHIBITOR, BLU-667, IN PATIENTS WITH THYROID CANCER, NON-SMALL CELL LUNG CANCER (NSCLC) AND OTHER ADVANCED SOLID TUMORS (BLU-667-1101) SPONSOR: BLUEPRINT MEDICINE
GROUP 1 - PATIENTS MUST HAVE PATHOLOGICALLY DOCUMENTED, DEFINITIVELY DIAGNOSED LOCALLY ADVANCED OR METASTATIC NSCLC WITH A RET REARRANGEMENT THAT WAS PREVIOUSLY TREATED WITH A MULTI-KINASE INHIBITOR (MKI) THAT INHIBITS RET, SUCH AS CABOZANTINIB, LENVATANIB, VANDETANIB, PONATINIB, SORAFENIB AND ALECTINIB. GROUP 2 - PATIENTS MUST HAVE PATHOLOGICALLY DOCUMENTED, DEFINITIVELY DIAGNOSED LOCALLY ADVANCED OR METASTATIC NSCLC WITH A RET REARRANGEMENT THAT WAS NOT PREVIOUSLY TREATED WITH A MKI. GROUP 3 - PATIENTS MUST HAVE PATHOLOGICALLY DOCUMENTED, DEFINITIVELY DIAGNOSED ADVANCED MTC THAT HAS PROGRESSED WITHIN 14 MONTHS PRIOR TO THE SCREENING VISIT AND WAS PREVIOUSLY TREATED WITH A MKI. GROUP 4 - PATIENT MUST HAVE PATHOLOGICALLY DOCUMENTED, DEFINITELY DIAGNOSTED ADVANCED MTC THAT HAS PROGRESSED WITHIN 14 MONTHS PRIOR TO THE SCREENING VISIT AND WAS NOT PREVIOUSLY TREAT WITH A MKI. GROUP 5 -PATIENTS MUST HAVE A PATHOLOGICALLY DOCUMENTED, DEFINITIVELY DIAGNOSED ADVANCED SOLID TUMOR WITH AN ONCOGENIC RET REARRANGEMENT/FUSION OR MUTATION, OTHER THAN NSCLC AND MTC. GROUP 6 - PATIENT MUST HAVE A PATHOLOGICALLY DOCUMENTED, DEFINITELY DIAGNOSED ADVANCED SOLID TUMOR WITH AN ONCOGENIC RET REARRANGEMENT/FUSION OR MUTATION THAT WAS PREVIOUSLY TREATED WITH A PREVIOUS SELECTIVE TKI THAT INHIBITS RET UROTHELIAL:
19094 PROOF 302 QBGJ398-302: PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF INFIGRATINIB FOR THE ADJUVANT TREATMENT OF SUBJECTS WITH INVASIVE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS SPONSOR QED THERAPEUTICS
HAVE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED, INVASIVE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 ALTERATIONS WITHIN 120 DAYS FOLLOWING NEPHROURETERECTOMY, DISTAL URETHRECTOMY, OR CYSTECTOMY IF THE PATIENT RECEIVED NEOADJUVANT CHEMOTHERAPY, PATHOLOGIC STAGE AT SURGICAL RESECTION MUST BE AJCC STAGE >YPT2 AND/OR YN+. IF THE PATIENT DID NOT RECEIVE NEOADJUVANT CHEMOTHERAPY:
A.MUST BE INELIGIBLE TO RECEIVE CISPLATIN-BASED ADJUVANT CHEMOTHERAPY PER THE GALSKY CRITERIA:
- CREATININE CLEARANCE < 60CC/MIN OR
- >GRADE 2 HEARING LOSS OR
- >GRADE 2 NEUROPATHY)
B.PATHOLOGIC STAGE MUST BE AJCC STAGE >PT2 PN0-2 M0 (POST-LYMPHADENECTOMY OR NO LYMPHADENECTOMY [PNX]) FOR UPPER TRACT DISEASE. C.PATHOLOGIC STAGE SHOULD BE AJCC STAGE >PT3 OR PN+ (BLADDER CANCER). 18033 A PHASE 2 STUDY OF STIRAVATINIB IN COMBINATION WITH PDL1 CPI REGIMENS IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCIOMA SPONSOR: MIRATI
Confirmed Urothelial (transitional Cell) Carcinoma with metastatic/unresectable, locally advanced disease Can no have active Brain metastasis

17133 THOR STUDY: PHASE 3 STUDY OF ERDAFITINIB COMPARED WITH VINFLUNINE OR DOCETAXEL OR PEMBROLIZUMAB IN SUBJECTS WITH ADVANCED UROTHELIAL CANCER AND FGFR GENE ABERRATIONS SPONSOR: JANSSEN
METASTATIC OR SURGICALLY UNRESECTABLE UROTHELIAL CANCER DOCUMENTED PROGRESSION OF DISEASE, DEFINED AS A PROGRESSION THAT REQUIRES A CHANGE IN TREATMENT PRIOR TO RANDOMIZATION  
 
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