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P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Clinical Trials | Clareo Health

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P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT03113487•City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53 (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving p53MVA and pembrolizumab together may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Detailed Description

PRIMARY OBJECTIVE: I. To assess response rate (complete responses and partial responses) after treatment with p53MVA and pembrolizumab. SECONDARY OBJECTIVE: I. To assess median progression free survival (PFS), clinical benefit (complete response, partial response lasting \> 6 months), overall survival (OS), safety and tolerability. EXPLORATORY OBJECTIVE: I. Evaluate if the CD8+ T cell signal exceeds that detected in the single agent p53MVA trial. OUTLINE: This is a dose-escalation study of modified vaccinia virus ankara vaccine expressing p53. Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks and modified vaccinia virus ankara vaccine expressing p53 subcutaneously (SC) every 3 weeks for up to 3 vaccines. Cycles with pembrolizumab repeat every 3 weeks for up to 49 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1-3 weeks and every 12 weeks thereafter.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants with histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer will be enrolled in this study; patients must have experienced recurrence or progression within 6 months after completion of platinum based chemotherapy (by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria).
•A patient is eligible to participate if she is not pregnant, not breast-feeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment
•The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
•Have measurable disease based on RECIST 1.1., or detectable disease; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
•Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI); lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT, PET/CT, or MRI
•* Detectable disease in a patients is defined as one who does not have measurable disease, but has at least one of the following conditions:
•* Baseline values of CA-125 at least 2 x upper limit of normal (ULN)
•* Ascites and/ or pleural effusion attributed to tumor
•* Solid and/ or cystic abnormalities on radiographic imaging that do not meet modified RECIST criteria, immune-related response criteria (irRC) for target lesions
•Patients whose ovarian cancer recurs/progresses within 0-6 months following platinum-based chemotherapy have platinum resistant or refractory disease; these patients are not considered to benefit from additional platinum-based therapy and are treated with other sequential single agents; such patients are eligible for this trial
+16 more criteria

Exclusion Criteria

•A WOCBP who has a positive urine pregnancy test within 72 hours prior to study treatment start; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
•Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment start
•* Note: participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline; participants with =\< grade 2 neuropathy may be eligible
•* Note: if participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
•Has received prior radiotherapy within 3 weeks of start of study treatment; participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis; a 1-week washout is permitted for palliative radiation (=\< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease
•Has received a live vaccine within 30 days prior to the first dose of study drug; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment; Note: participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
•Has a diagnosis of immunodeficiency (including organ grafts and human immunodeficiency virus \[HIV\]), or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug (exceptions: nasal corticosteroids, inhaled steroids, adrenal replacement steroids and steroid creams are allowed)
•Has a known additional malignancy that is progressing or has required active treatment within the past 3 years; Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or any carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
+14 more criteria

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

February 1, 2018

Primary Completion Date

August 26, 2022

Completion Date

May 4, 2026

Last Updated

July 20, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Platinum-Resistant Fallopian Tube CarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Platinum-Resistant Primary Peritoneal Carcinoma

Interventions

Modified Vaccinia Virus Ankara Vaccine Expressing p53

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

NCT04739800

Fallopian Tube Mucinous AdenocarcinomaOvarian Seromucinous Carcinoma+48 more

View study

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: July 20, 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.

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