COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Compugen Ltd
Study ID
NCT04570839
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

Key Dates

Start date
Aug 31, 2020
Status verified
Jul 2024
Primary completion
May 15, 2024
Completion
May 15, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohorts.
    Up to 5 sequential dose escalation cohorts of COM701 in combination with fixed doses of BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks until a maximum tolerated dose or recommended dose for expansion is identified.
  • Experimental: Cohort 1 Expansion Cohort A (ovarian cancer)
    Single arm: subjects with platinum resistant/refractory epithelial ovarian cancer, primary peritoneal or fallopian tube cancer will be randomized to receive study treatment with COM701 in combination with BMS-986207 and nivolumab. The study drugs will be administered IV every 4 weeks.
  • Experimental: Cohort 2 Expansion Cohort (endometrial cancer).
    Single arm: subjects with MSS-endometrial cancer will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
  • Experimental: Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors).
    Single arm: subjects with tumor types with high expression of PVRL2 will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
  • Experimental: Cohort 4 Expansion Cohort (Head and Neck cancer).
    Two arms: subjects with head and neck cancer. Equal number of subjects in each of the 2 arms. One arm will enroll subjects who have not previously received treatment with an immune checkpoint inhibitor, the other arm will enroll subjects who have received prior treatment with an immune checkpoint inhibitor. All subjects will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.

Primary Outcome Measure

The proportion of subjects with adverse events on the study. [ Time Frame: 2 years. ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-
Johns Hopkins University Oncology Center.BaltimoreMaryland21231-
Massachusetts General HospitalBostonMassachusetts02114-
START Midwest.Grand RapidsMichigan49503-
Columbia UniversityNew YorkNew York10032-
University of Pittsburgh Cancer Center.PittsburghPennsylvania15232-
The University of Tennessee WEST Cancer Center.MemphisTennessee38138-
MD Anderson Cancer CenterHoustonTexas77030-
The START Center for Cancer Care.San AntonioTexas78229-

Find similar trials in Chicago, IL

By condition
Head and neck cancerOvarian cancer
By specialty
OncologyENTGynecologic oncologyWomen's health
By research site
University of Chicago Medical Center· Chicago, ILJohns Hopkins University Oncology Center.· Baltimore, MDMassachusetts General Hospital· Boston, MASTART Midwest.· Grand Rapids, MIColumbia University· New York, NYUniversity of Pittsburgh Cancer Center.· Pittsburgh, PA

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