Phase 2
Completed N=14
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
epithelial ovarian cancer · Peritoneal Cancer · Fallopian tube cancer
Source: ClinicalTrials.gov NCT02915523 ↗
Enrolled (actual)
14
Serious AEs
43.2%
Results posted
Jan 2024
Primary outcomePrimary: Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — 1.51; 1.64 months
Summary
The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose in terms of progression free survival compared to avelumab plus placebo in participants with refractory or recurrent epithelial ovarian cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
1.51; 1.64 | — |
| PRIMARY Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) |
0; 1 | — |
| SECONDARY Phase 1b: Recommended Phase 2 Dose (RP2D) |
5 | — |
| SECONDARY Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) |
2.10; 1.77 | — |
| SECONDARY Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 |
4.88; 5.88 | — |
| SECONDARY Phase 2: ORR, as Assessed Using irRECIST |
2.44; 4.71 | — |
| SECONDARY Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1 |
9.76; 11.76 | — |
| SECONDARY Phase 2: CBR, as Assessed Using irRECIST |
9.76; 9.41 | — |
| SECONDARY Phase 2: Overall Survival |
10.55; 12.85 | — |
| SECONDARY Phase 2: Duration of Response |
6.83; 4.21 | — |
| SECONDARY Phase 2: Time to Response |
2.10; 2.79 | — |
| SECONDARY Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death |
6; 8; 1; 0; 1; 4 | — |
| SECONDARY Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death |
39; 85; 1; 1; 17; 39 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Avelumab When Given in Combination With Entinostat |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer
- Recurrent or progressive disease on or after initial platinum-based chemotherapy
- Evidence of measurable disease based on imaging studies within 28 days before the first dose of study drug
- Previously received at least 3, but no more than 6, lines of therapy including at least 1 course of platinum-based therapy
- Participant must have acceptable, applicable laboratory requirements
- Participants may have a history of brain metastasis provided certain protocol criteria are met
- Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade ≤1 (except alopecia or neuropathy)
- Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria
- Non-epithelial ovarian carcinomas or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Another known malignancy that is progressing or requires active treatment (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Previously treated with a histone deacetylase inhibitor (i.e., vorinostat, belinostat, romidepsin, panobinostat), PD-1/PD-L1-blocking antibody (i.e., atezolizumab, nivolumab, pembrolizumab), or a cytotoxic T-lymphocyte associated protein-4 (CTLA-4) agent
- Currently enrolled in (or completed) another investigational drug study within 30 days prior to study drug administration
- A medical condition that precludes adequate study treatment or increases participant risk
Data sourced from ClinicalTrials.gov (NCT02915523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.