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Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
Phase 1, PHASE2 trial testing Rintatolimod in Ovarian Cancer Recurrent in 24 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Robert Edwards |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 28 January 2019 |
| Primary completion | 1 July 2024 |
| Estimated completion | 10 January 2027 |
| Sites | 1 location across United States |
Robert Edwards
18 and older, female only, with Ovarian Cancer Recurrent. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 50 | 31 – 69 |
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, all
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 6.8 | ± 44.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 21.5 | ± 13.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 28.4 | ± 19.3 |
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 57.9 | ± 28.9 |
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 76 | ± 32 |
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 91.3 | ± 6.5 |
Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 90.5 | ± 8.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | -14.4 | ± 13.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | 22.5 | ± 15.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cisplatin + Rintatolimod + Pembrolizumab | -7.8 | ± 19.8 |
Time frame: Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cisplatin + Rintatolimod +… |
|---|---|---|
| Abdominal pain | GASTROINTESTINAL DISORDERS | — |
| Fever | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | — |
| Hyperglycemia | METABOLISM AND NUTRITION DISORDERS | — |
| Vomiting | GASTROINTESTINAL DISORDERS | — |
| Small intestinal perforation | GASTROINTESTINAL DISORDERS | — |
| Small intestinal obstruction | GASTROINTESTINAL DISORDERS | — |
| Obstruction gastric | GASTROINTESTINAL DISORDERS | — |
| Nausea | GASTROINTESTINAL DISORDERS | — |
| Fatigue | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | — |
| Sepsis | INFECTIONS AND INFESTATIONS | — |
| Device related infection | INFECTIONS AND INFESTATIONS | — |
| Hyponatremia | METABOLISM AND NUTRITION DISORDERS | — |
| Hypokalemia | METABOLISM AND NUTRITION DISORDERS | — |
| Dehydration | METABOLISM AND NUTRITION DISORDERS | — |
| Erythema multiforme | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | — |
| Failure to thrive | SOCIAL CIRCUMSTANCES | — |
| Hypotension | VASCULAR DISORDERS | — |
| Reaction | System | Cisplatin + Rintatolimod +… |
|---|---|---|
| Fatigue | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | — |
| Hypomagnesemia | METABOLISM AND NUTRITION DISORDERS | — |
| Nausea | GASTROINTESTINAL DISORDERS | — |
| Anemia | BLOOD AND LYMPHATIC SYSTEM DISORDERS | — |
| Abdominal pain | GASTROINTESTINAL DISORDERS | — |
| Hypertension | VASCULAR DISORDERS | — |
| Hyponatremia | METABOLISM AND NUTRITION DISORDERS | — |
| Diarrhea | GASTROINTESTINAL DISORDERS | — |
| Bloating | GASTROINTESTINAL DISORDERS | — |
| Anorexia | METABOLISM AND NUTRITION DISORDERS | — |
| Neutrophil count decreased | INVESTIGATIONS | — |
| Vomiting | GASTROINTESTINAL DISORDERS | — |
| Lymphocyte count decreased | INVESTIGATIONS | — |
| White blood cell decreased | INVESTIGATIONS | — |
| Blood lactate dehydrogenase increased | INVESTIGATIONS | — |
| Headache | NERVOUS SYSTEM DISORDERS | — |
| Nasal congestion | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | — |
| Sinus tachycardia | CARDIAC DISORDERS | — |
| Pain | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | — |
| Hyperglycemia | METABOLISM AND NUTRITION DISORDERS | — |
| Constipation | GASTROINTESTINAL DISORDERS | — |
| Creatinine increased | INVESTIGATIONS | — |
| Hypophosphatemia | METABOLISM AND NUTRITION DISORDERS | — |
| Hypokalemia | METABOLISM AND NUTRITION DISORDERS | — |
| Back pain | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | — |
| Hypotension | VASCULAR DISORDERS | — |
| Chills | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | — |
| Urinary tract infection | INFECTIONS AND INFESTATIONS | — |
| Aspartate aminotransferase increased | INVESTIGATIONS | — |
| Tremor | NERVOUS SYSTEM DISORDERS | — |
| Rash maculo-papular | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | — |
| Tinnitus | EAR AND LABYRINTH DISORDERS | — |
| Dry mouth | GASTROINTESTINAL DISORDERS | — |
| Abdominal distension | GASTROINTESTINAL DISORDERS | — |
| Platelet count decreased | INVESTIGATIONS | — |
| Alkaline phosphatase increased | INVESTIGATIONS | — |
| Hypoalbuminemia | METABOLISM AND NUTRITION DISORDERS | — |
| Dehydration | METABOLISM AND NUTRITION DISORDERS | — |
| Generalized muscle weakness | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | — |
| Arthralgia | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | — |
Most-reported serious reactions: Abdominal pain, Fever, Hyperglycemia, Vomiting, Small intestinal perforation, Small intestinal obstruction, Obstruction gastric, Nausea.
Data from ClinicalTrials.gov NCT03734692 adverse events section.
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).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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