A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination with BMS-986207 (antiTIGIT antibody) and Nivolumab in Subjects with Advanced Solid Tumors (CPG-03-101)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Contact Us
(410) 955-8964Brief Summary
This study will be conducted in 2 parts, dose escalation and dose expansion. Dose Escalation - Testing the safety of increasing doses of COM701 in combination with fixed doses of nivolumab and BMS-986207. For subjects entering into this part of the study, COM701 increasing doses will be given with fixed doses of nivolumab and BMS-986207. Dose Expansion - Testing the safety of fixed doses of all 3 study drugs or one of the drugs (nivolumab) in subjects with certain types of cancer. Once the dose of COM701 to be used has been determined during dose escalation, the dose expansion will open. During dose expansion up to 60 subjects with specific tumors will receive either all 3 study drugs and 20 subjects will receive nivolumab alone, depending on which cohort (below) you are assigned to. These specific tumors include cancer of the ovary, uterus and some cancers that have a high level of a marker called PVRL2.
Eligibility
Key Inclusion Criteria:
- Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or is not a candidate for the available standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- During dose escalation - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti- CTLA-4, OX-40, CD137, etc., are eligible.
During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1.
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 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.
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-naïve.