JNJ-87704916 + Cetrelimab for Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Must not be taking: Antivirals, Antibiotics

Disqualifiers: CNS disease, Herpetic infections, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called JNJ-87704916 by itself and with another drug called cetrelimab. It aims to find out if these drugs are safe and how they should be dosed. The study likely targets patients who need new treatment options and works by affecting disease pathways or boosting the immune system.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic anti-infective agents (like antibiotics, antifungals, or antivirals), you must stop them at least 7 days before starting the study treatment.

What data supports the effectiveness of the drug JNJ-87704916 + Cetrelimab for cancer?

The research articles provided do not contain direct information about the effectiveness of JNJ-87704916 + Cetrelimab for cancer. However, they discuss the effectiveness of similar immune-oncology treatments like pembrolizumab and ipilimumab plus nivolumab, which have shown benefits in treating advanced melanoma and non-small-cell lung cancer, suggesting potential for similar therapies. ^{1 2 3 4 5}

How does the drug JNJ-87704916 + Cetrelimab differ from other cancer treatments?

The drug JNJ-87704916 + Cetrelimab is unique because it combines cetrelimab, a monoclonal antibody that inhibits PD-1 (a protein that helps cancer cells evade the immune system), with another component, potentially offering a novel approach to treating advanced cancers by enhancing the body's immune response against tumors. ^{6 7 8 9 10}

Research Team

Johnson & Johnson Enterprise Innovation Inc Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors who have tried all standard treatments without success. They should be relatively active and well (ECOG grade 0 or 1) and not expecting a child, with measures taken to prevent pregnancy during the study.

Inclusion Criteria

Have at least 1 injectable tumor

A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study

I have a solid tumor cancer that has spread, and I've tried all standard treatments.

Exclusion Criteria

Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome

I have had a solid organ or bone marrow transplant.

I haven't taken antibiotics or other infection-fighting drugs in the last 7 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with advanced solid tumors receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels are sequentially tested.

Up to 5 years

Dose Expansion

Participants with metastatic non-small cell lung cancer receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1.

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

100 days

Treatment Details

Interventions

• Cetrelimab (Monoclonal Antibodies)
• JNJ-87704916 (Monoclonal Antibodies)

Trial Overview The study is testing JNJ-87704916 both alone and combined with another drug called cetrelimab. It aims to find safe dosages and treatment schedules for patients with tough-to-treat solid tumors.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 2 Interventions

Part 2 will consist of two cohorts: Cohort A and Cohort B. Participants in both Cohorts with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1.

Group II: Part 1: Dose Escalation Experimental Treatment 2 Interventions

Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.

Who Is Running the Clinical Trial?

Johnson & Johnson Enterprise Innovation Inc.

Lead Sponsor

Trials

5

Recruited

910+

Findings from Research

In patients with advanced non-small-cell lung cancer (NSCLC) and high PD-L1 expression (≥50%), cemiplimab showed significant improvements in progression-free survival (PFS) and objective response rate (ORR) compared to pembrolizumab, based on a systematic review and network meta-analysis of randomized-controlled trials.

Cemiplimab demonstrated comparable overall survival (OS) and similar safety profiles to pembrolizumab, indicating it is a viable first-line treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network meta-analysis of immune-oncology monotherapy as first-line treatment for advanced non-small-cell lung cancer in patients with PD-L1 expression ⩾50. Freemantle, N., Xu, Y., Wilson, FR., et al.[2022]

In a study of 302 patients with advanced non-small-cell lung cancer (NSCLC) and high PD-L1 expression treated with pembrolizumab, those with a performance status (PS) of 0-1 had a significantly higher response rate (72%) compared to those with PS 2 (45%).

Patients with PS 2 experienced poorer outcomes, with a median progression-free survival of only 2.6 months and median overall survival of 7.8 months, highlighting PS 2 as a strong predictor of poor response and survival in this treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab. Friedlaender, A., Metro, G., Signorelli, D., et al.[2021]

In a phase 1b study involving 41 treatment-naïve patients with advanced nonsmall-cell lung cancer (NSCLC), the combination of sintilimab (a PD-1 inhibitor) with chemotherapy showed promising antitumor activity, with objective response rates of 68.4% for nonsquamous NSCLC and 64.7% for squamous NSCLC.

The treatment was associated with manageable toxicity, as 38.1% of patients with nonsquamous NSCLC and 85.0% of patients with squamous NSCLC experienced grade 3-4 adverse events, indicating that while side effects occurred, they were within a tolerable range.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open-label, phase 1b study. Jiang, H., Zheng, Y., Qian, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Network meta-analysis of immune-oncology monotherapy as first-line treatment for advanced non-small-cell lung cancer in patients with PD-L1 expression ⩾50. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of pembrolizumab in advanced melanoma: analysis of a French national clinicobiological database. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Real-world Outcomes of Ipilimumab Plus Nivolumab Combination Therapy in a Nation-wide Cohort of Advanced Melanoma Patients in the Netherlands. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC in the Phase 3 ORIENT-11 Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Real-world efficacy and safety data of nivolumab and ipilimumab combination therapy in Japanese patients with advanced melanoma. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open-label, phase 1b study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumors. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. [2022]