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T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer
Phase 1, PHASE2 trial testing Ipilimumab in Metastatic Ovarian Cancer in 6 participants. Terminated before completion.
| Lead sponsor | Inge Marie Svane |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 22 April 2021 |
| Primary completion | 3 March 2024 |
| Estimated completion | 3 March 2024 |
| Sites | 1 location across Denmark |
Inge Marie Svane — full company profile →
Adults 18 to 75, any sex, with Metastatic Ovarian Cancer or Metastatic Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study
| Group | Value | 95% CI |
|---|---|---|
| Without Ipilimumab | 0 | |
| With Ipilimumab | 0 |
The number of Participants Experiencing Grade III or Worse Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| Without Ipilimumab | 5 | |
| With Ipilimumab | 0 | |
| Without Ipilimumab | 0 | |
| With Ipilimumab | 0 |
Number of patients excluded due to feasibility issues compared to the number of patients enrolled in the study
| Group | Value | 95% CI |
|---|---|---|
| Without Ipilimumab | 1 | |
| With Ipilimumab | 0 |
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Without Ipilimumab | 3 | |
| With Ipilimumab | 0 | |
| Without Ipilimumab | 2 | |
| With Ipilimumab | 0 |
Time frame: The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Without Ipilimumab | With Ipilimumab |
|---|---|---|---|
| Bacterial infection | Infections and infestations | — | — |
| Ileus (small intestine) | Gastrointestinal disorders | — | — |
| Atrial febrillation | Cardiac disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Colon ileus | Gastrointestinal disorders | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Kidney failure | General disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Hyperthyroidism | Endocrine disorders | — | — |
| Bacterial infection during neutropenia | Infections and infestations | — | — |
| Reactivation of Cytomegalo virus | Infections and infestations | — | — |
| Reaction | System | Without Ipilimumab | With Ipilimumab |
|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Hyponetriemia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Trombocytopenia | Blood and lymphatic system disorders | — | — |
| Decrease in PS | General disorders | — | — |
| Fatique | General disorders | — | — |
| Fever | General disorders | — | — |
| Pain | Musculoskeletal and connective tissue disorders | — | — |
| Infections | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Obstipation | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Obstipation | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Elevated ALAT/ASAT | Hepatobiliary disorders | — | — |
| Maculopapular rash | Skin and subcutaneous tissue disorders | — | — |
| Hyperthyroidism | Endocrine disorders | — | — |
| Increased p-ferritin | Blood and lymphatic system disorders | — | — |
| Oral candida | Infections and infestations | — | — |
| Troponine increase | Cardiac disorders | — | — |
| Increased ferritin | Blood and lymphatic system disorders | — | — |
| Elevated creatinine | Renal and urinary disorders | — | — |
Most-reported serious reactions: Bacterial infection, Ileus (small intestine), Atrial febrillation, Pulmonary embolism, Colon ileus, Gastroenteritis, Kidney failure, Pericardial effusion.
Data from ClinicalTrials.gov NCT04611126 adverse events section.
Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances. In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed. Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function. In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction. With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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