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Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387227
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
United States Department of Defense
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial investigates how well pembrolizumab and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). 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. Chemotherapy drugs, such as carboplatin, 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 together with carboplatin may work better in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Drug: Carboplatin Biological: Pembrolizumab Phase 2

Detailed Description:

OUTLINE:

Patients receive carboplatin intravenously (IV) over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 30 days, then every 3 months for year 1, and every 6 months for year 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-PD-1 in Combination With Carboplatin to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 3, 2023
Estimated Study Completion Date : April 3, 2024


Arm Intervention/treatment
Experimental: Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: At 6 months ]
  2. Rate of radiographic recurrence [ Time Frame: At 6 months ]

Secondary Outcome Measures :
  1. Programmed cell death ligand 1 (PD-L1) expression [ Time Frame: Up to 2 years ]
    Evaluated by immunohistochemistry staining in combined tumor and inflammatory cells in which positivity will be defined by > 1% staining.

  2. PD-L2 expression [ Time Frame: Up to 2 years ]
    Evaluated by immunohistochemistry staining in combined tumor and inflammatory cells in which positivity will be defined by > 1% staining.

  3. Changes in T cell activation [ Time Frame: Baseline and 2 years ]
    Flow cytometry will be performed on peripheral blood mononuclear cells

  4. Overall survival [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
  • Have a cancer antigen (CA)-125 that normalized after first-line therapy
  • CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
  • Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic
  • All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study
  • Have estimated life expectancy of at least 3 months
  • Be willing and able to provide written informed consent/assent for the trial
  • Have a performance status of 0 or 1 on the on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) > 1,500/mcL (performed within 10 days of treatment initiation)
  • Platelets > 100,000/mcL (performed within 10 days of treatment initiation)
  • Hemoglobin (Hgb) > 9g/dL or > 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
  • Serum creatinine < 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance > 60mL/min for subject with creatinine levels < 1.5 X institutional ULN (performed within 10 days of treatment initiation)
  • Serum total bilirubin < 1.5 X ULN OR direct bilirubin < ULN for subjects with total bilirubin levels > 1.5 X ULN (performed within 10 days of treatment initiation)
  • Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine transferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X ULN OR < 5 X ULN for subjects with liver metastases (performed within 10 days of treatment initiation)
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless patient is receiving anticoagulant therapy (as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants) (performed within 10 days of treatment initiation)
  • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless patient is receiving anticoagulant therapy (as long as PT or PTT is within therapeutic range of intended use of anticoagulants) (performed within 10 days of treatment initiation)

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
  • 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
  • Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed
  • Has symptomatic ascites or pleural effusions
  • History of borderline or low malignant potential ovarian cancer
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Has had a prior anti-cancer monoclonal antibody (mAb) 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: Patients with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
    • Note: If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • 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. Patients 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 trial 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 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 a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  • Clinically significant cardiovascular disease
  • Known severe hypersensitivity reactions to monoclonal antibodies or carboplatin >= grade 3, any history of anaphylaxis, or uncontrolled asthma
  • Has received prior therapy with pembrolizumab
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a live vaccine within 30 days of planned start of study therapy.

    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387227


Contacts
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Contact: Kris Kauno 206-543-3829 kkauno@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Contact: Kris Kauno    206-543-3829    kkauno@uw.edu   
Principal Investigator: John B. Liao         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
United States Department of Defense
Investigators
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Principal Investigator: John B. Liao Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT04387227    
Other Study ID Numbers: RG1007137
NCI-2020-02615 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RG1007137 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
W81XWH1910009 ( Other Grant/Funding Number: Department of Defense (DOD) )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological