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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 belowSelect...
I have an advanced cancer that has spread, including to the brain.
Select...
My condition worsened after my last treatment and there are no good alternative treatments.
Select...
I have melanoma or colorectal cancer and have received certain approved treatments.
Select...
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.
Select...
I am not on any cancer drugs or small molecule treatments as the study starts.
Select...
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
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 moreSecondary 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 moreAwards & 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
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.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,666 Previous Clinical Trials
17,860,215 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,551 Previous Clinical Trials
14,901,356 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of retinal vein occlusion or muscle disorders with high CK levels.I have an advanced cancer that has spread, including to the brain.My condition worsened after my last treatment and there are no good alternative treatments.I have melanoma or colorectal cancer and have received certain approved treatments.My cancer has a specific BRAF gene change.I am not on any cancer drugs or small molecule treatments as the study starts.I have a brain tumor larger than 4 cm.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy dose escalation (Part 1)
- Group 2: Combination dose escalation (Part 2)
- Group 3: Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
- Group 4: Dose expansion (Part 3) - Tumor and mutation specific Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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