Status:
TERMINATED
Pembrolizumab + Idelalisib for Lung Cancer Study
Lead Sponsor:
Asha Nayak
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Gilead Sciences
Conditions:
Non Small Cell Lung Cancer
Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1b/2 study to determine the safety and effectiveness of the combination of pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune therapy. This s...
Detailed Description
This is a phase 1b/2 study to determine the safety and effectiveness of the combination of pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune therapy. Pembro...
Eligibility Criteria
Inclusion
- All subjects must have documented metastatic or recurrent NSCLC from biopsy. They must have failed or progressed on platinum-based chemotherapy (e.g. cisplatin, carboplatin) as well as immune checkpoint inhibitor therapy (e.g nivolumab or pembrolizumab). Patients with EGFR/ALK mutations/translocations must have failed or progressed on small molecule inhibitor therapies (e.g. erlotinib, afatinib, etc.).
- Have at least one measurable lesion
- Have an ECOG Performance Status of 1 or less
- Demonstrate adequate organ function as defined in the protocol.
- Female subjects of childbearing potential must have a negative pregnancy test before starting treatment; they must also be willing to use two methods of birth control or abstain from heterosexual activity for the duration of the study.
- Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through the duration of the study.
Exclusion
- Is currently receiving study drug in another trial; or has participated in an investigational drug study within 3 weeks of the first dose of treatment.
- Is within 3 weeks of most recent chemotherapy.
- Has a history of hypersensitivity to pembrolizumab or idelalisib, or any of their excipients.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated, stable, brain metastases may participate; carcinomatous meningitis is excluded regardless of clinical stability.
- Has known history of non-infectious pneumonitis that required steroid use or has current pneumonitis.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has active autoimmune disease that has required treatment; known history of Human Immunodeficiency Virus (HIV); known active Hepatitis B or Hepatitis C.
- Has an active infection requiring systemic therapy.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03257722
Start Date
September 26 2017
End Date
August 25 2021
Last Update
February 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912