What side effects are associated with this type of intervention?

Common treatments for solid tumors, including immune checkpoint inhibitors like cetrelimab, chemotherapy, and targeted therapies, have a range of side effects. Immune checkpoint inhibitors can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy often leads to myelosuppression, nausea, vomiting, fatigue, and increased risk of infections. Targeted therapies may result in hypertension, diarrhea, liver toxicity, and skin issues. Each treatment's side effect profile varies, and patients should discuss these with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA approvals for the treatment of solid tumors have included several immune checkpoint inhibitors, such as pembrolizumab (Keytruda) and nivolumab (Opdivo), which target the PD-1 pathway. These drugs have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Combination therapies involving these agents, such as nivolumab with ipilimumab (Yervoy), have also received approval for enhanced efficacy in treating advanced solid tumors. These treatments work by enhancing the body's immune response against cancer cells, similar to the investigational approach of combining JNJ-87704916 with cetrelimab.

What other types of research exist?

Promising novel alternatives for solid tumor patients include multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib. Immunotherapies like pembrolizumab and nivolumab are also potential options. Additionally, oral JAK inhibitors like abrocitinib and upadacitinib may be considered for specific cases.

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Monoclonal Antibodies

JNJ-87704916 + Cetrelimab for Cancer

Phase 1

Recruiting

Research Sponsored by Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of JNJ-87704916 and cetrelimab may include typical reactions like fatigue, nausea, skin issues, immune-related conditions, as well as potential injection site reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events (AEs) by Severity

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

Secondary study objectives

Part 2: Overall Survival (OS)

Part 2: Progression Free Survival (PFS)

Parts 1 and 2: Duration of Response (DOR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment2 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 EscalationExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab

2022

Completed Phase 1

~20

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects healthy cells, leading to side effects. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, boosts the body's immune system to recognize and destroy cancer cells. Targeted therapies focus on specific molecules involved in cancer growth and survival, minimizing damage to normal cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment with manageable side effects, improving outcomes and quality of life.