What side effects are associated with this type of intervention?

Common treatments for melanoma, such as binimetinib and cetuximab, have specific side effects. Binimetinib, a MEK inhibitor, can cause side effects like diarrhea, nausea, vomiting, fatigue, and skin rash. Cetuximab, an EGFR inhibitor, may lead to infusion reactions, skin rash, low magnesium levels, and gastrointestinal issues. These side effects are important considerations for patients undergoing treatment for melanoma.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of melanoma, particularly those targeting the BRAF mutation and MEK pathways. Vemurafenib and dabrafenib are BRAF inhibitors approved for patients with BRAF V600E mutations. Trametinib and cobimetinib are MEK inhibitors often used in combination with BRAF inhibitors to improve efficacy. Additionally, immunotherapies such as nivolumab and pembrolizumab, which are PD-1 inhibitors, have been approved for melanoma treatment. These therapies have significantly improved outcomes for patients with advanced melanoma.

What other types of research exist?

Promising novel alternatives for melanoma patients in 2024 include: 1) Combination of vemurafenib and rituximab, which has shown high response rates and prolonged remissions in clinical trials. 2) Dabrafenib and trametinib combination therapy, which targets BRAFV600E mutations and has demonstrated efficacy in multiple studies. 3) Selpercatinib, a selective RET inhibitor, which has shown efficacy in RET-altered cancers and may be relevant for certain melanoma subtypes. These alternatives offer targeted approaches and have shown promising results in clinical settings.

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PF-07799933 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Diagnosis of advanced/metastatic solid tumor including primary brain tumor

Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2)

Must not have

For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new medicine, PF-07799933, for people with advanced solid tumors that have a specific gene issue and haven't responded to other treatments. Participants will take PF-07799933 as a tablet regularly, and some may also take binimetinib or receive cetuximab shots. The goal is to see if these medicines are safe and effective.

Who is the study for?

This trial is for people with advanced solid tumors, including brain tumors, who have a specific abnormal BRAF gene and whose cancer has progressed after treatment. Participants must have tried certain therapies if they have melanoma or colorectal cancer. Those with large brain metastases or certain eye or muscle disorders cannot join.

What is being tested?

The study tests PF-07799933 alone and combined with binimetinib for melanoma/other solid tumors, or cetuximab for colorectal cancer. PF-07799933 is an oral tablet; binimetinib is also a tablet; cetuximab is an IV shot given in the clinic.

What are the potential side effects?

Potential side effects include typical reactions to oral medications like stomach upset, as well as more serious risks such as organ inflammation from immunotherapy drugs. Cetuximab may cause skin reactions and infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I have an advanced cancer that has spread, including to the brain.

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My condition worsened after my last treatment and there are no good alternative treatments.

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I have melanoma or colorectal cancer and have received certain approved treatments.

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My cancer has a specific BRAF gene change.

Exclusion Criteria

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

Select...

I do not have a history of retinal vein occlusion or muscle disorders with high CK levels.

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I am not on any cancer drugs or small molecule treatments as the study starts.

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I have a brain tumor larger than 4 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 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

Discontinuations due to AEs (Part 1 and Part 2)

Dose dose modifications due to AEs (Part 1 and Part 2)

Dose interruptions due to AEs (Part 1 and Part 2)

+8 more

Secondary study objectives

Number of participants with clinically significant physical exam abnormalities (Part 3)

Part 1 and Part 2: Duration of response

Part 1 and Part 2: ORR

+39 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalation (Part 1)Experimental Treatment1 Intervention

Participants will receive PF-07799933

Group II: Dose expansion (Part 3) - Tumor and mutation specific Cohort 2Experimental Treatment2 Interventions

Participants will receive PF-07799933

Group III: Dose expansion (Part 3) - Tumor and mutation specific Cohort 1Experimental Treatment1 Intervention

Participants will receive PF-07799933

Group IV: Combination dose escalation (Part 2)Experimental Treatment3 Interventions

Participants will receive PF-07799933 in combination with binimetinib or cetuximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

binimetinib

2018

Completed Phase 2

~140

cetuximab

2000

Completed Phase 3

~7290

0 / 7Eligibility 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

Common treatments for melanoma include targeted therapies and immunotherapies. Targeted therapies, such as BRAF inhibitors (vemurafenib, dabrafenib), block abnormal signaling pathways in cancer cells with BRAF mutations, inhibiting their growth. Immunotherapies, like checkpoint inhibitors (pembrolizumab, nivolumab), enhance the immune system's ability to recognize and attack melanoma cells. These treatments are significant for melanoma patients as they provide more personalized and effective options, particularly for advanced or treatment-resistant cases.