Ovarian Cancer RecurrentPhase 1/2NCT03734692
Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
A Phase 1/2 study testing Rintatolimod, Pembrolizumab and Cisplatin in people with Ovarian Cancer Recurrent, run by Robert Edwards at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- Rintatolimod, Pembrolizumab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 10 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
- The participant provides written informed consent for the trial.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 28 days prior to the date of allocation/randomization.
- Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 28days prior to the start of study treatment.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Has a known allergy to cisplatin chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA qualitative is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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).
Read the detailed description
Patients will receive a total of six treatment cycles, at 3-week intervals. The study will use an IP neoadjuvant approach (IP chemoimmunotherapy of cisplatin with IP rintatolimod and IV infusion of pembrolizumab), followed by interval cytoreduction (usually laparoscopically) of residual tumor. Cytoreduction will occur approximately 4 weeks after the fourth treatment cycle. Post-surgery the investigators will consolidate with 2 additional courses of same chemo-immunotherapy regimen. Catheter will be removed 12 weeks after the last treatment. All surgical procedures, if done laparoscopically, are outpatient and will yield up to three serial biopsies of the tumor sites: 1) at catheter placement; 2) at interval cytoreduction which consists of removal of any visible tumor sites and the site biopsied initially whether tumor is present or not; 3) at catheter removal, when site of first tumor biopsy will be re-biopsied for pathologic response.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- Rintatolimod, Pembrolizumab, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RintatolimodDrug
Also called Ampligen
200 mg by IP administration over 1-2 hours
PembrolizumabDrug
Also called Keytruda
200 mg will be administered as a 30 minute IV infusion
CisplatinDrug
Also called Platinol
50mg/m^2 solution
| Study group | Role | What they receive |
|---|---|---|
| cisplatin + rintatolimod + pembrolizumab | Experimental | Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Receives: Drug: Rintatolimod; Drug: Pembrolizumab; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 13 weeks
Secondary outcomes (53)
DLTs Related to Treatment
Number of patients who experience Adverse Events per CTCAE v5.0 related to study treatment, including any death not clearly due to disease or extraneous causes, AE leading to a dose delay of greater than 14 days in initiation of cycle 2, a DLT occurring during Cycle 1 of treatment: Grade ≥ 3 renal toxicity, diarrhea, skin toxicity, injection site reactions, anaphylaxis, hematologic toxicities lasting more than 48 hours (including neutropenia), non-hematologic toxicities, neurological symptoms, thrombocytopenia and hemorrhage, liver function test increase; Grade ≥ 2 or greater bronchospasm, allergic reaction or generalized urticaria, autoimmune reaction, pneumonitis; Fever > 41°C, uncontrolled for over 4 hours in the absence of a medical cause Evaluation of liver toxicity per Hy's Law: Drug causes hepatocellular injury (higher incidence of 3-fold or greater elevations above the ULN of ALT or AST); Total Bilirubin>2xULN (without initial cholestasis (elevated serum alkaline phosphatase)
Measured: At baseline (pre-treatment) and at 12 weeks (after the start of treatment)
Progression-Free Survival (PFS)
The length of time during and after study treatment that a patient does not experience worsening disease. Per RECIST 1.1 or dies from any cause. Progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions.
Measured: up to 4 years
Time To Disease Progression
The length of time during and after study treatment that a patient remains alive without worsening disease. Per RECIST 1.1, progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions.
Measured: up to 4 years
Change in CD45 Cells
Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD45 Cells
Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD45 Cells
Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD45 Cells
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD45 Cells
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD45 Cells
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD45 Cells
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD3 Cells
Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD3 Cells
Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD3 Cells
Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD3 Cells
Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD3 Cells
Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD3 Cells
Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD3 Cells
Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD4 Cells
Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD4 Cells
Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD4 Cells
Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD4 Cells
Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD4 Cells
Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD4 Cells
Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD4 Cells
Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD8 Cells
Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD8 Cells
Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD8 Cells
Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD8 Cells
Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD8 Cells
Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD8 Cells
Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD8 Cells
Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD14 Cells
Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD14 Cells
Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD14 Cells
Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD14 Cells
Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD14 Cells
Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD14 Cells
Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD14 Cells
Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD19 Cells
Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD19 Cells
Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD19 Cells
Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD19 Cells
Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD19 Cells
Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD19 Cells
Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD19 Cells
Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Change in CD56 Cells
Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 1 Day 3
Change in CD56 Cells
Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 1
Change in CD56 Cells
Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1.
Measured: At treatment Cycle 4 Day 3
Percent of CD56 Cells
Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 1
Percent of CD56 Cells
Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 1 Day 3
Percent of CD56 Cells
Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 1
Percent of CD56 Cells
Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment.
Measured: At treatment Cycle 4 Day 3
Overall Survival (OS)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start28 Jan 2019
- Primary completion1 Jul 2024
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Edwards
- Sponsor type
- University, hospital or other
- Collaborators
- AIM ImmunoTech Inc., Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Robert Edwards, University of Pittsburgh
- Investigators
- Robert Edwards, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734692
- Sponsor's protocol ID
- HCC 18-087
- Status last verified
- Jan 2026
- First submitted
- 6 Nov 2018
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03734692
- Acronym / sponsor ID
- HCC 18-087
- Conditions
- Ovarian Cancer Recurrent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Robert EdwardsUniversity, hospital or other
- Collaborators
- AIM ImmunoTech Inc., Merck Sharp & Dohme LLC
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients will receive a total of six treatment cycles, at 3-week intervals. The study will use an IP neoadjuvant approach (IP chemoimmunotherapy of cisplatin with IP rintatolimod and IV infusion of pembrolizumab), followed by interval cytoreduction (usually laparoscopically) of residual tumor. Cytoreduction will occur approximately 4 weeks after the fourth treatment cycle. Post-surgery the investigators will consolidate with 2 additional courses of same chemo-immunotherapy regimen. Catheter will be removed 12 weeks after the last treatment. All surgical procedures, if done laparoscopically, are outpatient and will yield up to three serial biopsies of the tumor sites: 1) at catheter placement; 2) at interval cytoreduction which consists of removal of any visible tumor sites and the site biopsied initially whether tumor is present or not; 3) at catheter removal, when site of first tumor biopsy will be re-biopsied for pathologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cisplatin + rintatolimod + pembrolizumab | Experimental | Drug: Rintatolimod, Drug: Pembrolizumab, Drug: CisplatinIntraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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:
Key exclusion criteria (25 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RintatolimodAlso: Ampligen200 mg by IP administration over 1-2 hours | Drug | cisplatin + rintatolimod + pembrolizumab |
| PembrolizumabAlso: Keytruda200 mg will be administered as a 30 minute IV infusion | Drug | cisplatin + rintatolimod + pembrolizumab |
| CisplatinAlso: Platinol50mg/m^2 solution | Drug | cisplatin + rintatolimod + pembrolizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: At 13 weeks
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.
53 secondary outcomes
DLTs Related to Treatment
Time frame: At baseline (pre-treatment) and at 12 weeks (after the start of treatment)
Progression-Free Survival (PFS)
Time frame: up to 4 years
Time To Disease Progression
Time frame: up to 4 years
Change in CD45 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD45 Cells
Time frame: At treatment Cycle 4 Day 1
Change in CD45 Cells
Time frame: At treatment Cycle 4 Day 3
Percent of CD45 Cells
Time frame: At treatment Cycle 1 Day 1
Percent of CD45 Cells
Time frame: At treatment Cycle 1 Day 3
Percent of CD45 Cells
Time frame: At treatment Cycle 4 Day 1
Percent of CD45 Cells
Time frame: At treatment Cycle 4 Day 3
Change in CD3 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD3 Cells
Time frame: At treatment Cycle 4 Day 1
Change in CD3 Cells
Time frame: At treatment Cycle 4 Day 3
Percent of CD3 Cells
Time frame: At treatment Cycle 1 Day 1
Percent of CD3 Cells
Time frame: At treatment Cycle 1 Day 3
Percent of CD3 Cells
Time frame: At treatment Cycle 4 Day 1
Percent of CD3 Cells
Time frame: At treatment Cycle 4 Day 3
Change in CD4 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD4 Cells
Time frame: At treatment Cycle 4 Day 1
Change in CD4 Cells
Time frame: At treatment Cycle 4 Day 3
Percent of CD4 Cells
Time frame: At treatment Cycle 1 Day 1
Percent of CD4 Cells
Time frame: At treatment Cycle 1 Day 3
Percent of CD4 Cells
Time frame: At treatment Cycle 4 Day 1
Percent of CD4 Cells
Time frame: At treatment Cycle 4 Day 3
Change in CD8 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD8 Cells
Time frame: At treatment Cycle 4 Day 1
Change in CD8 Cells
Time frame: At treatment Cycle 4 Day 3
Percent of CD8 Cells
Time frame: At treatment Cycle 1 Day 1
Percent of CD8 Cells
Time frame: At treatment Cycle 1 Day 3
Percent of CD8 Cells
Time frame: At treatment Cycle 4 Day 1
Percent of CD8 Cells
Time frame: At treatment Cycle 4 Day 3
Change in CD14 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD14 Cells
Time frame: At treatment Cycle 4 Day 1
Change in CD14 Cells
Time frame: At treatment Cycle 4 Day 3
Percent of CD14 Cells
Time frame: At treatment Cycle 1 Day 1
Percent of CD14 Cells
Time frame: At treatment Cycle 1 Day 3
Percent of CD14 Cells
Time frame: At treatment Cycle 4 Day 1
Percent of CD14 Cells
Time frame: At treatment Cycle 4 Day 3
Change in CD19 Cells
Time frame: At treatment Cycle 1 Day 3
Change in CD19 Cells
Time frame: At treatment Cycle 4 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer Recurrent
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Edwards, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rintatolimod, Pembrolizumab and Cisplatin in people with Ovarian Cancer Recurrent, run by Robert Edwards at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: At 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.