What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving novel therapeutic agents like INCB081776 and anti-PD-1 antibodies such as INCMGA00012, include immune-related adverse events. These can range from mild to severe and often involve the skin (rash, pruritus), gastrointestinal tract (diarrhea, colitis), liver (hepatitis), and endocrine system (thyroiditis, adrenal insufficiency). Severe adverse events, though less common, can include pneumonitis and severe colitis. The combination of these agents may increase the risk of such immune-related side effects, necessitating close monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly focusing on immune checkpoint inhibitors. Pembrolizumab and nivolumab, both anti-PD-1 antibodies, have been approved for various cancers including melanoma and non-small cell lung cancer. Ipilimumab, an anti-CTLA-4 antibody, has also been approved for melanoma. These treatments work by enhancing the body's immune response against cancer cells. The combination of nivolumab and ipilimumab has shown efficacy in treating advanced melanoma. These approvals highlight the FDA's support for immunotherapy in treating solid tumors, similar to the investigational combination of INCB081776 and INCMGA00012.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab (an anti-PD-1 antibody) which has shown efficacy in various cancers including melanoma and non-small cell lung cancer. 2) Nivolumab (another anti-PD-1 antibody) often used in combination with Ipilimumab (a CTLA-4 inhibitor) for enhanced efficacy in melanoma and other cancers. 3) Atezolizumab (an anti-PD-L1 antibody) which has demonstrated effectiveness in non-small cell lung cancer and mesothelioma. 4) Venetoclax plus Obinutuzumab, particularly for chronic lymphocytic leukemia, but showing potential in solid tumors. These alternatives have shown promising results in clinical trials and may offer effective treatment options for solid tumor patients.

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INCB081776 + INCMGA00012 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Male and female participants at least 18 years of age with advanced malignancies who have received or been intolerant to standard therapy

Cohorts 1-3 must have received 1 prior PD-1/L1 treatment and have experienced PD during or after that treatment and have progressed on other SOC therapy(ies); Cohort 4 must be PD-1/L1 treatment naïve but have progressed on SOC therapy(ies)

Must not have

Active infection requiring systemic therapy

Clinically significant cardiac disease as per protocol-defined criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug alone and with another drug to see if they are safe, how they work in the body, and if they show early signs of effectiveness in patients needing new treatments.

Who is the study for?

This trial is for adults with advanced malignancies, including melanoma, lung cancer (NSCLC), head and neck cancer (SCCHN), soft-tissue sarcoma, and others. Participants must have measurable disease and may have received prior treatments as specified per cohort. They should be willing to undergo tumor biopsies but cannot join if they have significant heart issues, active autoimmune diseases requiring recent treatment, certain infections like hepatitis or HIV, or haven't recovered from previous therapy side effects.

What is being tested?

The study tests the safety and effectiveness of INCB081776 alone (Part 1) and combined with INCMGA00012 (Part 2). It will assess how these drugs are processed in the body and their impact on tumors. The trial aims to find out if these interventions can help treat various types of advanced cancers by monitoring early clinical activity.

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like INCB081776 and INCMGA00012 might include fatigue, nausea, inflammation-related symptoms due to immune system activation, potential organ-specific toxicity such as liver or kidney issues, skin reactions at injection sites among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with advanced cancer and have tried or can't tolerate standard treatments.

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I have had one PD-1/L1 treatment and my cancer got worse, or I haven't had PD-1/L1 treatment but my cancer progressed after standard treatments.

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My cancer type matches one of the specified groups for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for an infection.

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I have a serious heart condition.

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I have an autoimmune disease that needed treatment in the last 2 years.

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My brain cancer has not been treated or is getting worse despite treatment.

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I still have side effects from previous treatments or surgeries that are not mild.

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I have been diagnosed with HIV.

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I have experienced severe side effects from previous immunotherapy.

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I have a history of eye retina disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1 (1A and 1B): Number of treatment-emergent adverse events (TEAEs)

Part 1 (1A and 1B): Recommended Dose for Expansion (RDE)

Part 2 (2A & 2B): Number of treatment-emergent adverse events

+1 more

Secondary study objectives

Part 1 and Part 2 : CL/F of INCB081776

Part 1 and Part 2 : Vz/F of INCB081776

Part 1 and Part 2 : λz of INCB081776

+10 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: INCB081776 + INCMGA00012Experimental Treatment2 Interventions

INCB081776 in combination with INCMGA00012.

Group II: INCB081776Experimental Treatment1 Intervention

Single-agent INCB081776.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCMGA00012

2021

Completed Phase 1

~60

0 / 11Eligibility criteria met

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

The most common treatments for solid tumors include novel therapeutic agents and immunotherapies such as anti-PD-1 antibodies. Novel therapeutic agents, like INCB081776, often target specific pathways or mutations within cancer cells, disrupting their growth and survival. Anti-PD-1 antibodies, such as INCMGA00012, work by blocking the PD-1 pathway, which tumors use to evade the immune system. By inhibiting this pathway, these antibodies enhance the body's immune response against cancer cells. These mechanisms are crucial for solid tumor patients as they offer targeted and potentially more effective treatment options, improving outcomes and reducing side effects compared to traditional therapies.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.