Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

NCT03734692 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 1 other identifier: HCC 18-087
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II single arm efficacy/safety trial that will evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP rintatolimod (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer (OC).

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a \> 30% decrease in size of lesion from baseline.

  At 13 weeks

Secondary Outcomes (53)

• DLTs Related to Treatment

  At baseline (pre-treatment) and at 12 weeks (after the start of treatment)

• Progression-Free Survival (PFS)

  up to 4 years

• Time To Disease Progression

  up to 4 years

• Change in CD45 Cells

  At treatment Cycle 1 Day 3

• Change in CD45 Cells

  At treatment Cycle 4 Day 1

Other Outcomes (3)

• NK Cells

  at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

• Grandzyme B

  at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

• CD4 Tbet

  at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Study Arms (1)

cisplatin + rintatolimod + pembrolizumab

EXPERIMENTAL

Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution.

Drug: Rintatolimod; Drug: Pembrolizumab; Drug: Cisplatin

Interventions

Rintatolimod DRUG

200 mg by IP administration over 1-2 hours

Also known as: Ampligen

cisplatin + rintatolimod + pembrolizumab

Pembrolizumab DRUG

200 mg will be administered as a 30 minute IV infusion

Also known as: Keytruda

cisplatin + rintatolimod + pembrolizumab

Cisplatin DRUG

50mg/m\^2 solution

Also known as: Platinol

cisplatin + rintatolimod + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ovarian cancer is limited to the female population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years of age on the day of signing informed consent.
• Patients must have first or second peritoneal recurrence of epithelial adenocarcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin:
• Histologic documentation of the original primary tumor is required via the pathology report.
• Original tumor blocks from the primary diagnosis will be requested by our study pathologist at Magee-Women's Hospital of UPMC Cancer Centers if the patient did not have their initial surgery at Magee. Original tumor blocks may be reviewed after registration (informed consent and enrollment). Tumor block should be held until study is completed.
• Patients must have completed prior platinum-based therapy. Response can be complete or partial if it otherwise meets platinum sensitive criteria, see below.
• Patients must be platinum-sensitive, defined as having a progression free interval (PFI) of more than 6 months (180 days) from any platinum therapy. Patients are allowed to have had other lines of therapy since last platinum if PFI after platinum therapy meets platinum sensitive criteria.
• Patients must have measurable disease in the peritoneal cavity, measurable per RECIST 1.1 criteria:
• A mass with a length of 1.0 cm or greater and/or
• A lymph node with a length of 1.5 cm or greater in the shortest axis.
• Patients must be a reasonable candidate for laparoscopy and IP platinum regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity or bowel obstruction.
• Patients of childbearing potential must:
• Have a negative pregnancy test prior to the study entry.
• Must discontinue breastfeeding prior to the first date of treatment on this study if applicable.
• Agree to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
• Patients must agree to the protocol designated clinical monitoring to receive the study regimens.

You may not qualify if:

• A WOCBP who has a positive urine pregnancy test within 72 hours prior to infusion of treatment regimen (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
• Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
• Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
• Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
• Patients with previous pelvic radiation therapy.
• Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
• o Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Patients with tumors of low malignant potential, except ovarian pseudomyxomas, or with no peritoneal disease.
• Concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non- melanomatous skin cancer or curatively resected cervical cancer or per physician discretion that the previous cancer was adequately treated with curative intent and unlikely to recur (the study PI must concur with this determination).
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

Sponsors & Collaborators

• Robert Edwards: lead
• AIM ImmunoTech Inc.: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

poly(I).poly(c12,U); pembrolizumab; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Barbara Stadterman, MPH, CCRP
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

4126475554

Study Officials

• Robert Edwards, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: January 28, 2019
• Primary Completion: July 1, 2024
• Study Completion (Estimated): January 10, 2027
• Last Updated: February 12, 2026
• Results First Posted: July 20, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)