JNJ-87704916 + Cetrelimab for Cancer

Recruiting at 6 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

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.

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
• 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.

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 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 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 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]

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]

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]

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 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]

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]

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]

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]