Status:
COMPLETED
Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors
Lead Sponsor:
Baptist Health South Florida
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Miami Cancer Institute
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 pembrolizuma...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Sufficient tissue is available for correlative studies
- MSI studies have been performed, either by immunohistochemistry or next generation sequencing and results show that patient is MS low or stable.
Exclusion
- 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.
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03274661
Start Date
November 3 2017
End Date
March 19 2022
Last Update
October 19 2023
Active Locations (1)
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1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176