Testing COM701 Maintenance Treatment to Delay Cancer Growth After Platinum Chemotherapy for Ovarian Cancer That Has Come Back

About the Study

This study tests whether COM701 (an anti‑PVRIG immunotherapy) given every 3 weeks as maintenance can delay cancer growth after a good response to platinum chemotherapy. Adults with relapsed platinum‑sensitive ovarian, fallopian tube, or primary peritoneal cancer are randomized 2:1 to COM701 or placebo. Visits include regular safety checks and scans. The trial is open at multiple centers in the U.S., France, and Israel.

What the Study Involves

This is a randomized, double‑blind, placebo‑controlled, parallel‑group maintenance trial. 

• Screening/qualification: Medical history review, physical exam, labs/urine, ECG, baseline CT/MRI (within ~28 days), and tumor tissue (archival preferred; fresh biopsy if needed).
• Treatment & schedule:
  • COM701 (IV) or placebo IV every 3 weeks, up to ~2 years (max 35 doses).
  • Routine visit assessments: physical exam, vitals, labs (including thyroid/liver/kidney), CA‑125, periodic ECG and ctDNA per schedule.
• Imaging/monitoring:
  • Year 1: scans every 9 weeks;
  • Year 2: every 12 weeks;
  • Additional scans if clinically indicated or at the end of treatment.
• Research samples: PK and ADA blood samples (e.g., Cycle 1, 6, 12, and 30 days post‑last dose). Optional tumor biopsy around Cycle 2/3.
• Follow‑up: End‑of‑treatment visit within 7 days; safety follow‑up at Day 30 (visit) and Days 60 & 90 (calls). If stopping for reasons other than progression, scans are performed every 9 weeks up to 1 year.
• Compensation: ask your site about reimbursement for travel/parking or other costs.
• Additional time beyond standard care: Clinic infusion every 3 weeks with research blood draws and scheduled imaging as above

You may be eligible if you:

• Are 18 or older and female
• Have relapsed platinum‑sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Completed 2 or more prior platinum‑based treatment courses.
• In your most recent platinum regimen, received 4 or more cycles and achieved a partial or complete response.
• Previously received bevacizumab or a PARP inhibitor if eligible, and are not a candidate for (or declined) these options now.
• Have recovered from prior treatment side effects to Grade ≤1 (except alopecia ; neuropathy ≤Grade 2).

You would not be eligible if you:

• Have had 4 or more total lines of cytotoxic chemotherapy.
• Received checkpoint inhibitors before (PD‑1/PD‑L1, anti‑PVRIG, TIGIT, etc.).
• Need immunosuppressive systemic steroids (or similar) within 2 weeks before first dose.
• Have liver metastases at the start or end of the current platinum line.
• Required ascites drainage during the last two cycles of your most recent chemo or after finishing it.
• Had a bowel obstruction in the past 6 weeks.
• Have active CNS metastases, active HBV/HCV/HIV, or an uncontrolled infection.
• Are pregnant/breastfeeding, or received a live vaccine within 30 days of starting.