Study on Pembrolizumab for Treating Advanced, Recurrent, or Locally Advanced Cancer with Genomic Instability
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT03428802
This clinical trial is testing how well the drug pembrolizumab works in treating cancers that have spread, come back, or are locally advanced, especially in patients with certain genetic changes in their tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This phase II study is exploring the effectiveness of pembrolizumab, a type of monoclonal antibody, in treating cancers that have spread to other parts of the body, returned after treatment, or spread to nearby tissues or lymph nodes. Pembrolizumab may help stop tumor cells from growing and spreading.
Description
Primary Objectives:
- To see how well pembrolizumab works in patients with solid tumors that have specific genetic changes (mutations in POLE, POLD1, BRCA1, or BRCA2) and show signs of genomic instability.
Secondary Objectives:
- To compare the response rates and how long the response lasts in this study to past data from patients treated with pembrolizumab.
Tertiary Objectives:
- To study the immune response in the tumor and blood before and after treatment with pembrolizumab.
- To measure PD-L1 levels in tumor samples before and after treatment and see how it relates to patient outcomes.
- To perform genetic tests to find any links between genetic changes and treatment response.
- To analyze tumor samples for specific genetic markers that might predict response to treatment.
Treatment Plan:
Participants will receive pembrolizumab through an IV infusion every 21 days, as long as the cancer does not progress or side effects are manageable. If the cancer progresses, treatment may continue for up to one year. After finishing the treatment, participants will have follow-up visits at 30 days and then every 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written consent for the trial.
- Have a tumor with specific genetic changes (POLE, POLD1, BRCA1, or BRCA2 mutations) confirmed by a certified lab test.
- Have advanced cancer that is measurable by standard criteria.
- Willing to provide a tumor tissue sample for analysis.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Meet specific blood count and organ function criteria based on recent tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control during the study and for 120 days after the last dose.
- Men must agree to use contraception or abstain from sex during the study and for 120 days after the last dose.
Exclusion Criteria
- Currently participating in another study or have used an investigational drug within 4 weeks before starting this study.
- Have an immune deficiency requiring steroid or immunosuppressive therapy.
- Have a history of active tuberculosis (TB).
- Allergic to pembrolizumab or its ingredients.
- Have had recent treatment with certain cancer therapies and not fully recovered from side effects.
- Have another active cancer requiring treatment, except for certain skin cancers or in situ cervical cancer.
- Have untreated or unstable brain metastases.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have an active infection needing treatment.
- Have a condition or treatment that might interfere with the study.
- Pregnant or breastfeeding, or planning to conceive or father a child during the study.
- Have received prior therapy with similar drugs (anti-PD-1, anti-PD-L1, or anti-PD-L2).
- Have a history of HIV.
- Have received a live vaccine within 30 days before starting the study.
- Have tumors with specific genetic changes showing microsatellite instability.
- Have active hepatitis B or C infections.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.