What side effects are associated with this type of intervention?

Monoclonal antibody treatments, such as cetuximab, rituximab, and immune checkpoint inhibitors like pembrolizumab and nivolumab, commonly cause side effects including infusion reactions (fever, chills, and rash), fatigue, and gastrointestinal issues (nausea, diarrhea). Immune-related adverse events are also frequent, such as pneumonitis, colitis, hepatitis, endocrinopathies (thyroid dysfunction), and skin reactions (rash, pruritus). These side effects result from the immune system's heightened activity against both cancerous and normal cells.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of tumors, particularly those targeting specific cancer cell markers or modulating the immune system. Cetuximab and rituximab are examples of monoclonal antibodies used in combination with other therapies for various cancers. Ipilimumab, pembrolizumab, and nivolumab are immune checkpoint inhibitors that have been approved for treating advanced melanoma, non-small cell lung cancer, and other malignancies. These drugs work by targeting proteins such as PD-1, PD-L1, and CTLA-4 to enhance the immune system's ability to fight cancer.

What other types of research exist?

Promising alternatives to CC-95251 for tumor patients include: <ol> <li>Pembrolizumab: An anti-PD-1 therapy shown to be effective in various cancers, including non-small cell lung cancer and Merkel cell carcinoma.</li> <li></li> </ol> Atezolizumab: An anti-PD-L1 therapy used in combination with other agents for renal cell carcinoma and urothelial carcinoma. 3. Nivolumab: An anti-PD-1 therapy used in combination with ipilimumab for renal cell carcinoma and mesothelioma. 4. Enfortumab Vedotin: An antibody-drug conjugate for advanced urothelial carcinoma. 5. Mosunetuzumab: A bispecific antibody showing durable responses in relapsed or refractory B-cell lymphomas.

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Monoclonal Antibody

CC-95251 for Blood Cancers

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Eastern cooperative oncology group performance status of 0 or 1

Be older than 18 years old

Must not have

Has cancer with symptomatic central nervous system (CNS) involvement

High-grade lymphomas (Burkitt's or lymphoblastic)

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 CC-95251 to see if it is safe and effective for patients with advanced cancers. It is also being tested with two other cancer drugs to see if they work better together.

Who is the study for?

This trial is for adults with advanced solid tumors or blood cancers who have measurable disease, are in good physical condition (able to perform daily activities), and whose cancer has worsened despite standard treatments. It's not for those with high-grade lymphomas, recent severe heart issues, or cancer affecting the brain causing symptoms.

What is being tested?

The study tests CC-95251 alone and combined with cetuximab (for certain solid tumors) or rituximab (for specific blood cancers). The goal is to assess safety and early signs of effectiveness in treating these advanced cancers.

What are the potential side effects?

Possible side effects include reactions at the injection site, allergic responses, fatigue, nausea. Since CC-95251 is new, part of this study's purpose is to learn more about its side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

Exclusion Criteria

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

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My cancer has spread to my brain or spinal cord and is causing symptoms.

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My condition is a type of high-grade lymphoma.

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

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: CC-95251 in combination with rituximabExperimental Treatment2 Interventions

CC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.

Group II: CC-95251 in combination with cetuximabExperimental Treatment2 Interventions

CC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.

Group III: CC-95251Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-95251

2022

Completed Phase 1

~60

Cetuximab

2011

Completed Phase 3

~2480

Rituximab

1999

Completed Phase 4

~2990

0 / 3Eligibility 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

Monoclonal antibodies, such as those being studied in the trial CC-95251, target specific markers on cancer cells to block growth signals, mark the cells for immune destruction, or deliver cytotoxic agents directly to the cancer cells. Immune checkpoint inhibitors enhance the body's natural immune response by blocking proteins that prevent immune cells from attacking cancer cells. These targeted treatments are important for tumor patients as they can offer more effective and less toxic alternatives to traditional chemotherapy.