A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

Study Identifier:
CPG-03-101
CT.gov Identifier:
NCT04570839
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Study Complete

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Study Summary

To evaluate the safety, tolerability and antitumor activity of COM701 in combination with Opdivo® and BMS-986207.

To evaluate the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

To evaluate a safe and tolerable dose of the combination during dose escalation and antitumor activity in selected tumor types in the expansion cohorts (ovarian cancer, endometrial cancer and a biomarker-driven arm of tumor types with high expression of PVRL2).

To evaluate DNAM axis hypothesis in patients with advanced solid tumors.

Key objectives were to evaluate the safety and tolerability, to determine the recommended dose for expansion (RDFE) and to characterize preliminary pharmacokinetic parameters

We hypothesized that in pts with PROC, blocking the DNAM axis with the triplet: COM701 + BMS-986207 + nivolumab, would demonstrate antitumor activity with a favorable safety and tolerability profile. We present preliminary results.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bowel (Colorectal)
  • Non-Small Cell Lung Cancer
  • Ovarian
  • Pancreas
  • Prostate
  • Melanoma
  • Gastric
  • Head & Neck
  • Solid Tumor
  • Endometrial
  • Esophageal
  • Fallopian Tube
  • Primary Peritoneal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation Cohorts.
    • Read More
  • Drug: Experimental: Cohort 1 Expansion Cohort A (ovarian cancer)
  • Drug: Experimental: Cohort 2 Expansion Cohort (endometrial cancer).
  • Drug: Experimental: Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors).
  • Drug: Experimental: Cohort 4 Expansion Cohort (Head and Neck cancer).
  • Drug: 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.
  • Drug: Intervention:
  • Drug: Per SITC-2021
  • Drug: SITC 2021:
  • Drug: EIOC 2022:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Age > or = 18 yrs, histologically confirmed locally advanced or metastatic solid malignancy and has exhausted all available standard treatments.
    • Expansion Cohorts:
    • Cohort 1 (subjects with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma)
    • Subject must have platinum refractory/resistant ovarian cancer defined as refractoriness to platinum-containing regimen or disease recurrence < 6 months after completion of a platinum-containing regimen
    • Cohort 2 (endometrial cancer cohort)
    • Subjects with locally advanced or metastatic microsatellite stable endometrial cancer with disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy.
    • Subjects must have documented MSS status by an approved test e.g. genomic testing, IHC for mismatch repair proficient.
    • Subjects must have received no more than 2 prior systemic cytotoxic therapies; there are no limits to the number of prior endocrine or antiangiogenic regimens
    • Cohort 3 (basket cohort, excludes tumor types in cohorts 1 and 2)
    • Tumor types with high expression of PVRL2 (determined by central testing).
    • Cohort 4 (Head and Neck cancer)
    • Histologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, nasopharyngeal)
    • Cohort 4a - IO naïve. Eligible subjects can be systemic therapy naïve (frontline) or platinum failure.
    • Cohort 4b - IO failure. No limitations on the number of prior lines of systemic therapy.
    • Key inclusion criteria: Age ≥ 18 yrs, measurable disease, MSS by IHC or genomic testing, ≤2 prior systemic cytotoxic therapies, prior PD-1/PD-L1 permissible.
    • Key inclusion criteria: Age ≥ 18 yrs, histologically confirmed advanced malignancies and exhausted all available standard tx.
    • Exclusion Criteria:
    • Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
    • Symptomatic interstitial lung disease or inflammatory pneumonitis.
    • History of immune-related events that lead to immunotherapy treatment discontinuation.
    • Untreated or symptomatic central nervous system (CNS) metastases.
    Exclusion criteria
    • prior receipt of any inhibitor of PVRIG, TIGIT, or PD-1/PD-L1. Investigator assessed responses per RECIST v1.1, safety per CTCAE v5.0.
    • Key Exclusion Criteria For Dose Expansion Cohorts:
    • Cohort 1: Prior therapy with an anti-PD-1/PD-L1/2, COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody.
    • Cohort 2: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody. Subjects with MSI-H endometrial cancer are ineligible.
    • Cohort 3: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody are ineligible.
    • Cohort 4: Subjects who have received prior therapy with COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. Subjects in cohort 4a must be IO-naive.
    • Key exclusion criteria: history of immune-related toxicities on prior immunotherapy treatment leading to discontinuation.
    • Key exclusion criteria: prior receipt of any inhibitor of PVRIG, TIGIT, or PD-1/PD-L1. Investigator assessed responses per RECIST v1.1, safety per CTCAE v5.0.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Non-Small Cell Lung Cancer
    Ovarian
    Pancreas
    Prostate
    Melanoma
    Gastric
    Head & Neck
    Solid Tumor
    Endometrial
    Esophageal
    Fallopian Tube
    Primary Peritoneal
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Non-Small Cell Lung Cancer
    Ovarian
    Pancreas
    Prostate
    Melanoma
    Gastric
    Head & Neck
    Solid Tumor
    Endometrial
    Esophageal
    Fallopian Tube
    Primary Peritoneal