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CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300•Lan Coffman

View on ClinicalTrials.gov

Summary

This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.

Detailed Description

Clinically, there is a critical need for improved therapies in ovarian cancer. There has been recent success with maintenance therapy in ovarian cancer with both PARP inhibitors and bevacizumab approved in the up-front maintenance setting and in the recurrent, platinum sensitive maintenance setting. However, it is unclear what treatment should be used post-PARPi or bevacizumab maintenance. Additionally, the benefit derived from bevacizumab maintenance therapy is modest with generally a few month improvement in progression free survival. Further, there is emerging evidence that after progression on a PARPi, there is decreased response to platinum-based therapy. This provides a critical unmet need to enhance platinum response, particularly after previous maintenance therapy. This also provides a large group of patients who could potentially benefit from EZH2 targeting agents to block stromal-mediated chemotherapy resistance and metastasis. This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval after completion of chemotherapy by blocking stromal mediated chemotherapy resistance, metastasis promotion and ovarian cancer growth.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \> 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy).
•Documented disease recurrence/progression based on GCIG-RECIST
•Must have had at least 1 prior line of platinum-based therapy, prior bevacizumab or PARPi use are allowed. Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to consideration of clinical trial enrollment
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months
•Adequate organ function
•* Serum creatinine ≤1.5mg/dL or 24-hour clearance ≥50mL/min
•* AST/ALT \<2.5x ULN (or \<5x ULN if liver metastasis are present)
•* Total bilirubin ≤ ULN or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome
•* Hemoglobin ≥9 gm/dl, Platelets ≥100,000/μl ANC ≥1500/μl
•* INR ≤1.5
+10 more criteria

Exclusion Criteria

•Borderline or low malignant potential histology
•Platinum-resistant disease (as defined as progressive disease (PD) within 6 months of completion of chemotherapy with a platinum agent).
•Known hypersensitivity to any of the excipients of CPI-0209.
•Gastrointestinal (GI) dysfunction or disease that may significantly alter the absorption of the study drugs
•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).
•History of HIV infection
•Has an active infection requiring systemic treatment
•Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks and contraindicate patient's participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, significant cardiac/pulmonary disease etc.)
•Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
•Use of herbal supplements unless discontinued ≥7 days prior to initiation of study drug
+8 more criteria

Locations (1)

Magee-Womens Research Institute / UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

January 30, 2024

Primary Completion Date

November 1, 2026

Completion Date

December 31, 2028

Last Updated

June 19, 2025

Enrollment

ESTIMATED participants

Conditions

Recurrent Ovarian Cancer

Interventions

CPI-0209

DRUG

carboplatin

DRUG

Contacts

Kelsey Mitch, RN

CONTACT

412-623-6793 adamkka2@upmc.edu

Joshua Plassmeyer, MS

CONTACT

412-648-6417 plassmeyerjm@upmc.edu

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

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