PF-07799544 for Cancer

Recruiting at 44 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Brain metastasis, Retinal vein occlusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

124 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new cancer medicine, PF-07799544, taken regularly as a tablet. It is for people with advanced solid tumors who haven't responded to other treatments. The medicine may be used alone or with other drugs to improve its effectiveness.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the effectiveness of the drug PF-07799544 for cancer?

The research suggests that improvements in progression-free survival (PFS), which measures how long a patient lives without the cancer getting worse, can be an important indicator of a drug's effectiveness in treating cancer. While PFS benefits do not always lead to longer overall survival, they are considered valuable in assessing the clinical benefit of cancer drugs. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with advanced solid tumors, including brain and metastatic melanoma, where standard treatments no longer work. Participants need measurable disease by RECIST v1.1 criteria and must have progressed after the last treatment without other options. For certain substudies, a BRAF V600 mutation is required.

Inclusion Criteria

My cancer has a specific BRAF gene change.

My advanced cancer, except melanoma, didn't respond to standard treatments.

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

Exclusion Criteria

I have a brain tumor larger than 4 cm.

I have or had a blocked vein in my eye or a muscle disorder with high CK levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07799544 as a single agent or in combination with other study medicines for advanced solid tumors

2 years

Regular visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• encorafenib
• PF-07284890
• PF-07799544
• PF-07799933

Trial Overview The study tests PF-07799544 as a single agent or combined with other drugs in tablet form for advanced tumor patients. Some may also take encorafenib or additional study medicines like PF-07284890 or PF-07799933 depending on their gene type and study part.

Participant Groups

Group I: Phase 1b Substudy C Combination Dose Expansion Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group II: Phase 1b Substudy B Combination Dose Expansion Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group III: Phase 1b Substudy B Combination Dose Escalation Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group IV: Monotherapy Dose Escalation (Phase 1a) Experimental Treatment 2 Interventions

Participants will receive PF-07799544

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

The study found that the likelihood of translating a progression-free survival (PFS) benefit into an overall survival (OS) benefit is significantly influenced by the crossover rate and the length of survival post-progression (SPP).

Specifically, a crossover rate greater than 50% can greatly reduce the chances of observing an OS benefit, especially when combined with longer SPP times, indicating that these factors must be carefully considered in clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study. Zhang, L., Ko, CW., Tang, S., et al.[2020]

Overall survival (OS) is the traditional measure of clinical benefit for cancer drugs, but it requires large studies and long follow-up times, making it less practical for assessing new treatments quickly.

Progression-free survival (PFS) and time to progression (TTP) are valuable alternative endpoints that directly measure the effects of treatments on cancer growth, and their improvement can indicate clinical benefit, potentially speeding up the development and availability of effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Zhuang, SH., Xiu, L., Elsayed, YA.[2022]

In a real-world study involving 196 patients with metastatic colorectal cancer, the combination of bevacizumab and chemotherapy resulted in a median progression-free survival of 8.22 months, demonstrating its efficacy as a first-line treatment.

The treatment was generally safe, with the most common adverse event being hypertension (28%), and only 15.2% of patients experiencing severe (Grade 3/4) adverse events, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Non-Interventional Multicenter Study of First-Line Bevacizumab in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer in Lebanon. Temraz, S., Nasr, F., Kattan, J., et al.[2022]

In a review of 20 clinical trials involving 7,571 patients with metastatic colorectal cancer, targeted agents showed only minimal improvements in progression-free survival (PFS) and modest gains in overall survival (OS), suggesting limited efficacy in the second-line treatment.

The study found a moderate correlation between PFS and OS (R=0.734), but a poor correlation between objective response rate (ORR) and OS (R=0.169), indicating that OS should remain the primary endpoint in future trials for more reliable efficacy assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surrogate Endpoints in Second-Line Trials of Targeted Agents in Metastatic Colorectal Cancer: A Literature-Based Systematic Review and Meta-Analysis. Cremolini, C., Antoniotti, C., Pietrantonio, F., et al.[2022]

In a phase 3 trial involving 1717 men with metastatic castration-resistant prostate cancer, enzalutamide significantly reduced the risk of radiographic progression or death, demonstrating its efficacy as a treatment option.

The study confirmed a strong correlation between radiographic progression-free survival (rPFS) and overall survival (OS), supporting the use of rPFS as a meaningful endpoint in clinical trials for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. Rathkopf, DE., Beer, TM., Loriot, Y., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A Non-Interventional Multicenter Study of First-Line Bevacizumab in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer in Lebanon. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Surrogate Endpoints in Second-Line Trials of Targeted Agents in Metastatic Colorectal Cancer: A Literature-Based Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. [2020]