Anti-PD-1 Therapy for Advanced Cancers
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop any local or systemic anti-cancer treatments at least 14 days before starting the study drug, with a maximum of 28 days without these treatments. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug JNJ-63723283 for advanced cancers?
Research shows that PD-1 inhibitors, like JNJ-63723283, have been effective in treating various advanced cancers by improving survival rates. Similar drugs, such as nivolumab and pembrolizumab, have shown positive results in clinical trials, suggesting potential benefits for JNJ-63723283 as well.12345
Is anti-PD-1 therapy generally safe for humans?
How is the drug JNJ-63723283 different from other treatments for advanced cancers?
JNJ-63723283, also known as cetrelimab, is a monoclonal antibody that targets PD-1, a protein that tumors use to hide from the immune system. This drug is unique because it is specifically designed to block PD-1, potentially allowing the immune system to better recognize and attack cancer cells, which may offer a new option for patients with advanced cancers.12101112
What is the purpose of this trial?
The Primary purpose of this study is to identify the recommended Phase 2 dose \[RP2D(s)\] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4.
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with certain advanced cancers, including lung, melanoma, renal, bladder, and colorectal cancers. Participants must be in good physical condition (ECOG status 0 or 1), have normal thyroid function, not be pregnant or breastfeeding, and agree to study restrictions. Tissue samples are required for some parts of the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Part 1)
Participants receive JNJ-63723283 at a starting dose of 80 mg IV every 2 weeks, with dose escalation following a modified Continual Reassessment Method (mCRM)
Treatment (Part 2)
Participants receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1
Pharmacokinetic and Safety Evaluation (Part 3)
Participants receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD), and safety
Dose Confirmation (Part 4)
Participants receive JNJ-63723283 at the dose level determined in Part 3, with additional cohorts possibly enrolled
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- JNJ-63723283
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires