Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Matched Paired Pharmacodynamics and Feasibility Study of Pembrolizumab in Combination With Chemotherapy in Frontline Ovarian Cancer
2 other identifiers
interventional
31
1 country
5
Brief Summary
This phase II trial studies how well pembrolizumab works when given in combination with carboplatin and paclitaxel in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. 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. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab in combination with carboplatin and paclitaxel may be a better treatment for ovarian, primary peritoneal, or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2016
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
July 5, 2016
CompletedResults Posted
Study results publicly available
August 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2025
CompletedJune 8, 2025
May 1, 2025
8.9 years
August 7, 2015
November 16, 2023
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To Evaluate Progression-free Survival of Paclitaxel/Carboplatin and Pembrolizumab in Patients With Advanced Stage, Metastatic Ovarian Cancer Undergoing NACT
PFS was defined from the start of neoadjuvant therapy until the date of disease progression or death, whichever occurred first. Disease progression was evaluated using RECIST v1.1 guidelines. Patients who were alive without disease progression were censored at their last evaluation date or until withdrawal of consent. Patients who were removed off protocol for reasons other than disease progression, death, treatment toxicity, or withdrawal of consent were censored at the start date of their non-protocol treatment. Feasibility was defined as the ability to complete all planned 3 cycles of adjuvant carboplatin, paclitaxel, and pembrolizumab.
Up to 3 years
Secondary Outcomes (2)
To Describe the Feasibility of Combination Therapy and Maintenance Pembrolizumab in This Population
Up to 3 years
To Evaluate the Safety of Combination and Maintenance Pembrolizumab
up to 3 years
Study Arms (1)
Treatment (carboplatin, paclitaxel, and pembrolizumab)
EXPERIMENTALNACT: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. ADJUVANT THERAPY: Beginning 3-6 weeks after surgery, paclitaxel IV over 1 hour on days 1, 8, and 15, patients receive carboplatin IV over 1 hour on day 1, and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Signed, written informed consent
- Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
- No more than 4 prior cycles of chemotherapy for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube cancer
- No prior treatment involving irradiation, hormonal therapy, immunotherapy, investigational therapy, and/or other concurrent agents or therapies for ovarian cancer
- A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 4 complete cycles of treatment
- Planned dose-dense chemotherapy with combination carboplatin and paclitaxel given intravenously
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT
- Patients with non-measurable but evaluable solid tumors may be deemed eligible contingent upon principal investigator (PI) review
- Peripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Absolute neutrophil count (ANC) \>= 1,500 /mcL
- Platelets \>= 100,000/mcL
- Hemoglobin (Hgb) \>= 9 g/dL or \>= 5.6 mmol/L
- +9 more criteria
You may not qualify if:
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
- Histology showing mucinous or low grade epithelial ovarian carcinoma
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease \>= 5 years before the first dose of study drug and or low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
- Concomitant stage 1A/B, grade 1-2 endometrioid endometrial cancer as allowable contemporary tumor
- 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 four weeks prior to the first dose of study treatment 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 study treatment
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Patients with ovarian cancer not medically fit for diagnostic laparoscopy prior to initiation of therapy
- Patients with any evidence of severe or uncontrolled systemic disease (e.g. severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\], uncontrolled chronic renal disease \[glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis\]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension blood pressure \>= 140/90, active bleeding diatheses or active infection
- 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 study treatment
- Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 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
- No active autoimmune disease that has required systemic treatment in past two 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson in Katy
Houston, Texas, 77094, United States
MD Anderson League City
Nassau Bay, Texas, 77058, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
Related Publications (1)
How JA, Dang M, Lee S, Fellman B, Westin SN, Sood AK, Fleming ND, Shafer A, Yuan Y, Liu J, Zhao L, Celestino J, Hajek R, Morgan MB, Parra ER, Laberiano Fernandez CD, Arrechedera CA, Solis Soto LM, Schmeler KM, Nick A, Lu KH, Coleman R, Wang L, Jazaeri AA. Pembrolizumab plus chemotherapy in frontline treatment of advanced ovarian cancer: Clinical and translational results from a phase 2 trial. Med. 2025 Jan 10;6(1):100494. doi: 10.1016/j.medj.2024.07.022. Epub 2024 Aug 15.
PMID: 39151421RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amir Jazaeri MD
- Organization
- University of Texas M D Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Jazaeri, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 11, 2015
Study Start
July 5, 2016
Primary Completion
May 22, 2025
Study Completion
May 22, 2025
Last Updated
June 8, 2025
Results First Posted
August 29, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share