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Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

NCT02901899•Northwestern University

View on ClinicalTrials.gov

Summary

The purpose of this study is to look at how patients respond to treatment with guadecitabine and pembrolizumab. The researchers will also be looking at the amount of time it takes for cancer to get worse when participants take the study drugs. All participants will be treated with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA and can increase the production of certain proteins, making cancer cells more recognizable by the immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the combination of guadecitabine and pembrolizumab may increase the ability of the immune system to eliminate cancer cells. Researchers want to find out whether the combination of guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not responded to traditional chemotherapy. Participants will keep receiving treatment until their cancer gets worse, they have side effects, or they decide they don't want to receive the treatment anymore. After stopping treatment, the study doctor will watch participants for side effects and follow their condition every 6-12 weeks. The study aims to keep track of participants' medical conditions for the rest of their lives. This helps us look at the long-term effects of the study drugs.

Detailed Description

PRIMARY OBJECTIVES: I. Measure objective response rate (RR) to guadecitabine and pembrolizumab in subjects with recurrent platinum resistant ovarian cancer (OC). SECONDARY OBJECTIVES: I. Measure progression free survival (PFS) for the combination of guadecitabine and pembrolizumab. II. Progression free survival (PFS). III. Measure clinical benefit rate (CBR) for the combination of guadecitabine and pembrolizumab. IV. Measure toxicity profiles to the combination of guadecitabine and pembrolizumab. TERTIARY OBJECTIVES: I. NY-ESO-1 and MAGE antigens' promoter methylation (pyrosequencing) and messenger ribonucleic acid (mRNA) expression levels (quantitative reverse transcriptase-polymerase chain reaction \[RT-PCR\]) will be measured before and after treatment in deoxyribonucleic acid (DNA) (plasma and/or tumor biopsies) and ribonucleic acid (RNA) (tumor biopsies), respectively. II. Cytokine response (IFN gamma IL2, IL6, IL10, TNF alpha) will be measured in plasma by enzyme-linked immunosorbent assay (ELISA). III. Measure LINE 1 methylation in DNA extracted from peripheral blood mononuclear cells (PBMCs) (measured on days 1 and 5 of cycles 1 and 2). IV. Expression of the PD-L1 ligand will be measured by immunohistochemistry (IHC) in archival tumors. V. Tumor infiltrating lymphocytes (TILs) will be quantified in tumor biopsies before and after treatment (IHC). OUTLINE: Patients receive guadecitabine subcutaneously (SC) on days 1-4 and pembrolizumab intravenously (IV) over 30 minutes on day 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 6 weeks for 1 year, and then every 9 weeks and, once a subject experiences confirmed disease progression or starts a new anticancer therapy, every 3 months thereafter.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients must have a histological or cytological evidence/confirmation of recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis, or fallopian tube cancer
•Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to registration
•Prior therapy allowed:
•* At least one and no more than 3 platinum based chemotherapy regimens
•* Up to 2 non-platinum, cytotoxic regimen
•* There is no limit on use of prior biological therapies (hormonal or targeted therapy)
•* NOTE: Prior immunotherapy is not allowed
•Patients must exhibit an Eastern Cooperative Oncology Group (ECOG), performance status of 0-1 within 14 days prior to registration
•Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to treatment initiation:
•Absolute neutrophil count (ANC) \>= 1,500/mcL
+18 more criteria

Exclusion Criteria

•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to registration or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
•* NOTE: Subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
•* NOTE: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
•Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days prior to registration or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days registration
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days prior to registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
•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 received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; please contact the principal investigator for further clarification if needed
+12 more criteria

Locations (3)

Northwestern University

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Northwestern Lake Forest Hospital

Lake Forest, Illinois, United States

Key Dates

Start Date

November 11, 2016

Primary Completion Date

April 1, 2020

Completion Date

March 31, 2023

Last Updated

February 20, 2024

Enrollment

ACTUAL participants

Conditions

Recurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal Carcinoma

Interventions

Guadecitabine

DRUG

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

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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: February 20, 2024Data 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

Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy

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