JNJ-87704916 + Cetrelimab for Cancer

Recruiting at 7 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Must not be taking: Antivirals, Antibiotics

Disqualifiers: CNS disease, Herpetic infections, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and optimal dose of a new cancer treatment, JNJ-87704916, both alone and with cetrelimab (an immunotherapy). The focus is on advanced solid tumors and non-small cell lung cancer (NSCLC). Individuals who have exhausted all other treatments for their advanced or metastatic cancer and have at least one injectable tumor may be suitable for this study. The goal is to determine the most effective and safe way to use these treatments together. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cetrelimab, one of the treatments in this trial, has been tested in patients with advanced or hard-to-treat cancers. In these studies, most patients tolerated cetrelimab well, without serious issues. Some patients experienced side effects, but these were mostly manageable.

Cetrelimab has also shown promise in treating various types of cancer, including lung cancer, where many patients responded positively. This means the treatment helped shrink or slow down tumor growth in a significant number of patients.

In contrast, less information is available about the safety of JNJ-87704916. Since the current trial is in its early stages, the main goal is to find safe dosage levels. Researchers are still working to understand how well patients can tolerate this treatment, whether used alone or with cetrelimab.

Overall, while cetrelimab has demonstrated some safety and effectiveness, JNJ-87704916 is still under careful study to ensure its safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-87704916 combined with cetrelimab because it offers a novel approach to treating metastatic non-small cell lung cancer (NSCLC). Unlike standard treatments like chemotherapy or immune checkpoint inhibitors targeting PD-1 or PD-L1, JNJ-87704916 is being tested in combination with cetrelimab to potentially enhance immune response against cancer cells. This combination aims to target and disrupt cancer growth more effectively, potentially leading to improved outcomes for patients who may not fully respond to existing therapies.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that cetrelimab may help treat various types of cancer. In studies, about 18.6% of patients across different cancers responded to the treatment, meaning their cancer shrank or stopped growing. The response rate was even higher, at 34.3%, for patients with non-small cell lung cancer (NSCLC), indicating many NSCLC patients experienced tumor reduction or stabilization. This trial tests JNJ-87704916 both alone and with cetrelimab to evaluate their combined effectiveness. Earlier findings suggest that combining these treatments might enhance the body's ability to fight cancer. While more research is needed, early results are promising for those considering this treatment option. ^{2 3 6 7 8}

Who Is on the Research Team?

Johnson & Johnson Enterprise Innovation Inc Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cetrelimab
• JNJ-87704916

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

In the phase III KEYNOTE-189 study, pembrolizumab combined with pemetrexed and platinum-based chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) in patients with untreated metastatic nonsquamous non-small-cell lung cancer, with a hazard ratio of 0.56 for OS and 0.49 for PFS after a median follow-up of 31 months.

The treatment was associated with a high objective response rate (ORR) of 48.3% compared to 19.9% for the placebo group, and among patients who completed 35 cycles of pembrolizumab, the ORR was even higher at 85.7%, indicating strong efficacy with manageable toxicity.

NCBI (Pubmed)

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. Rodríguez-Abreu, D., Powell, SF., Hochmair, MJ., et al.[2022]

In a real-world study of 709 patients with advanced melanoma treated with ipilimumab plus nivolumab, 50.7% experienced severe treatment-related adverse events, highlighting the need for careful monitoring during therapy.

Despite the high rate of adverse events, the combination therapy showed promising long-term survival outcomes, with a median overall survival of 28.7 months and a 4-year overall survival rate of 50% for patients similar to those in the CheckMate-067 trial.

NCBI (Pubmed)

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. van Zeijl, MCT., van Breeschoten, J., de Wreede, LC., et al.[2023]

Cetrelimab, a PD-1 inhibitor, was found to have a manageable safety profile in patients with advanced solid tumors, with 53.9% experiencing grade ≥3 adverse events, and 35.3% having immune-related adverse events.

In terms of efficacy, cetrelimab showed an overall response rate of 18.6% across various tumor types, with higher rates in specific cancers like non-small-cell lung cancer (34.3%) and melanoma (28.0%), indicating its potential as a treatment option for these conditions.

NCBI (Pubmed)

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. Felip, E., Moreno, V., Morgensztern, D., 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 study of 397 patients with nonsquamous non-small cell lung cancer (NSCLC), the combination of sintilimab and chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with a median OS not reached versus 16.8 months for the placebo group.

High expression of the MHC class II antigen presentation pathway was strongly associated with better progression-free survival (PFS) and OS, indicating that this biomarker could help identify patients who would benefit most from the sintilimab and chemotherapy combination.

NCBI (Pubmed)

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. Yang, Y., Sun, J., Wang, Z., et al.[2021]

Pembrolizumab, an antibody targeting the PD-1 receptor, has shown strong antitumor effects and manageable safety in patients with advanced solid tumors, based on data from multiple studies including patients with melanoma and lung cancer.

The pharmacokinetic analysis indicates that the standard dose of 2 mg/kg every 3 weeks is effective across various patient subpopulations, with minimal need for dose adjustments based on factors like sex, tumor type, or prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumors. Ahamadi, M., Freshwater, T., Prohn, M., et al.[2018]

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]

In a study of 223 patients with advanced melanoma treated with pembrolizumab, the median overall survival was significantly higher for those starting treatment earlier, with 32.6 months for first-line therapy compared to 14.4 months for second-line and 9.3 months for third-line.

The treatment showed promising real-world effectiveness, with 49% of first-line patients achieving a complete or partial tumor response, indicating that pembrolizumab can be a beneficial option for advanced melanoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of pembrolizumab in advanced melanoma: analysis of a French national clinicobiological database. Casarotto, E., Chandwani, S., Mortier, L., et al.[2023]

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 57 Japanese patients with unresectable advanced melanoma, the combination therapy of nivolumab and ipilimumab showed an overall response rate of 26.3%, with a notably higher response rate of 40.7% in treatment-naive patients compared to 13.3% in those with prior systemic therapy.

The treatment was associated with significant adverse events, occurring in 86% of patients, with over half (56.1%) classified as grade 3 or worse, indicating that while the therapy can be effective, it also carries a substantial risk of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy and safety data of nivolumab and ipilimumab combination therapy in Japanese patients with advanced melanoma. Takahashi, A., Namikawa, K., Ogata, D., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35298698/

First-in-human, open-label, phase 1/2 study of the ... Overall response rate was 18.6% across tumor types, 34.3% in NSCLC, 52.6% in programmed death ligand 1-high (≥ 50% by immunohistochemistry) ...

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NCT05908734 | A Study of Combination Therapy With ... The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in ...

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Anti-PD-1 antibody cetrelimab (JNJ-63723283) in patients ... Here we present updated results from an ongoing phase 1/2 study of cetrelimab in patients (pts) with advanced or refractory solid cancers.

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Data published in The New England Journal of Medicine ... Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, ...

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First-in-human, open-label, phase 1/2 study of the monoclonal ... Immune-related AEs (any grade) occurred in 35.3% of patients (grade ≥ 3 in 6.9%). Overall response rate was 18.6% across tumor types, 34.3% in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02908906

NCT02908906 | A Study to Evaluate the Safety, ... 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 ...

7. jnj.com jnj.com/media-center/press-releases/neoadjuvant-tar-200-plus-cetrelimab-nearly-doubles-the-pathological-complete-response-rate-compared-to-cetrelimab-alone-in-patients-with-muscle-invasive-bladder-cancer

Neoadjuvant TAR-200 plus cetrelimab nearly doubles the ... TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of ...

8. xoma.com xoma.com/royaltyportfolio/jnj-63723283/

Cetrelimab (JNJ-63723283) - Clinical Trials ... Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer ... Solid Tumors · A Study of Combination Therapy With Amivantamab and Cetrelimab ...