Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors

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: NCT03274661
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Miami Cancer Institute
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
Phase II trial in which patients with metastatic solid tumors experiencing progression after first line standard chemotherapy or for which there is no standard chemotherapy, and for which pembrolizumab does not have an FDA or compendia listing approved indication, will receive pembrolizumab intravenously at a dose of 200 mg every 3 weeks.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: Pembrolizumab 200 mg Q3W Phase 2

Detailed Description:

Patients with metastatic or recurrent solid malignancy who have progressed on first line standard of care treatment or for which defined standard of care does not exist or is not readily available are eligible to participate on this trial. Patients for which pembrolizumab has an FDA approved indication and for whom pembrolizumab is covered by their insurance should receive standard commercial pembrolizumab and will not be eligible for this trial.

The primary objective of this trial is to evaluate the Immune-Related Objective Response Rate (IR-ORR) achieved with pembrolizumab in patients with Fanconi Anemia Repair Pathway functionally competent and functionally deficient tumors.

Trial treatment should be administered on Day 1 of each cycle after all procedures/assessments have been completed. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons.

All trial treatments will be administered on an outpatient basis.

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Target infusion timing is 30 minutes.

Expansion Cohort:

Ten (10) additional subjects with the diagnosis of metastatic or recurrent endometrial carcinoma will be enrolled in the trial at the conclusion of regular enrollment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible participants will receive pembrolizumab intravenously at a dose of 200 mg every 3 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Immune Checkpoint Inhibition In Solid Tumor Patients With Homologous Recombination Repair Deficiency
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : March 15, 2025
Estimated Study Completion Date : October 15, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab 200 mg Q3W
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Drug: Pembrolizumab 200 mg Q3W
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Other Name: Pembrolizumab 200 mg




Primary Outcome Measures :
  1. immune-related objective response rate [ Time Frame: every 2 cycles (3 weeks cycles); that is before every third dose of pembrolizumab ]
    Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy.


Secondary Outcome Measures :
  1. 20-week immune-related progression-free survival rate [ Time Frame: 20-week ]
    Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have measurable disease based on RECIST 1.1.
  • Be willing to provide consent for retrieval of archival tumor material tissue from a previously obtained core or excisional biopsy of a tumor lesion.
  • Have a tumor presentation at screening for which pembrolizumab does not have an FDA approved indication for commercial use.
  • Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
  • Demonstrate adequate organ function
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication.

Expansion cohort - additional criteria

  1. Diagnosis of Endometrial Carcinoma or Sarcoma which is metastatic and has failed standard treatment or is recurrent, or for which standard chemotherapy is contraindicated or refused by patient.
  2. Sufficient tissue is available for correlative studies
  3. MSI studies have been performed, either by immunohistochemistry or next generation sequencing and results show that patient is MS low or stable.

Exclusion Criteria:

  • 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 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.
  • 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 a known history of active Bacillus Tuberculosis
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable. 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).
  • Has immunohistochemically proven mismatch repair deficient cancer
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Evidence of interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • 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 or father 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.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV 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): NCT03274661


Contacts
Layout table for location contacts
Contact: John P Diaz, MD 786-596-2000 JohnPD@baptisthealth.net

Locations
Layout table for location information
United States, Florida
Miami Cancer Institute at Baptist Health, Inc. Recruiting
Miami, Florida, United States, 33176
Contact: John P Diaz, MD    786-596-2000    JohnPD@baptisthealth.net   
Principal Investigator: John P Diaz, MD         
Sponsors and Collaborators
Baptist Health South Florida
Merck Sharp & Dohme Corp.
Miami Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: John P Diaz, MD Miami Cancer Institute at Baptist Health, Inc.

Layout table for additonal information
Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT03274661    
Other Study ID Numbers: MK-3475-663
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baptist Health South Florida:
solid tumor, Pembrolizumab,
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents