230 Participants Needed

PC14586 for Solid Tumors

Recruiting at 84 trial locations
PP
Overseen ByPMV Pharma Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new oral drug, PC14586 (rezatapopt), alone and with pembrolizumab, in patients with advanced cancers that have a specific genetic mutation. The drug aims to fix a mutated protein to help control cancer growth. The study will determine the best dose and evaluate the drug's safety and effectiveness.

Will I have to stop taking my current medications?

The trial requires that you stop any anti-cancer therapy at least 21 days before starting the study drug. If you are taking strong CYP3A4 inducers, you may also need to stop those medications.

What safety information is available for pembrolizumab (Keytruda) in humans?

Pembrolizumab (Keytruda) has been associated with some common side effects like fatigue, cough, nausea, and rash, as well as more serious immune-related side effects such as pneumonitis (lung inflammation), colitis (inflammation of the colon), and thyroid disorders. Rarely, it can cause type 1 diabetes. These side effects have been observed in various cancer treatments.12345

What makes the drug PC14586 with Pembrolizumab unique for treating solid tumors?

PC14586 combined with Pembrolizumab is unique because Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-1 pathway, which is a mechanism tumors use to hide from the immune system. This combination may offer a novel approach for treating solid tumors by enhancing the body's immune response against cancer.14567

What data supports the effectiveness of the drug pembrolizumab (Keytruda) for treating solid tumors?

Pembrolizumab (Keytruda) has shown effectiveness in treating various solid tumors, including non-small cell lung cancer and melanoma, by improving survival rates compared to chemotherapy. It works by helping the immune system attack cancer cells more effectively.158910

Who Is on the Research Team?

MF

Marc Fellous, MD

Principal Investigator

Sr. Vice President of Medical Affairs

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have a specific mutation (TP53 Y220C) can join this trial. They should have tried other cancer treatments without success and be in good physical condition (ECOG 0 or 1). People with certain heart conditions, recent strokes, brain metastases needing steroids, or those on drugs affecting the immune system cannot participate.

Inclusion Criteria

My organs are working well.
My cancer has worsened despite previous treatments.
My cancer has a specific TP53 mutation.
See 1 more

Exclusion Criteria

My brain metastases are stable without needing steroids for symptoms.
I do not have recent severe heart problems or uncontrolled blood pressure.
My cancer started in the brain or spinal cord.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Monotherapy

Establish the maximum tolerated dose (MTD) and RP2D of rezatapopt, assess safety, tolerability, and preliminary efficacy

41 months

Phase 1b Combination Therapy

Evaluate safety, tolerability, and preliminary efficacy of rezatapopt in combination with pembrolizumab

30 months

Phase 2 Monotherapy

Evaluate the efficacy and safety of rezatapopt at the RP2D in various cancer cohorts

34 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PC14586
  • Pembrolizumab
Trial Overview The trial is testing PC14586 alone and combined with pembrolizumab to see how safe and effective they are for treating cancers with the TP53 Y220C mutation. Participants will receive different doses of PC14586 to find out which one works best.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Phase 2 Monotherapy Dose Expansion, Ovarian Cancer CohortExperimental Treatment1 Intervention
Group II: Phase 2 Monotherapy Dose Expansion, Other Solid Tumors CohortExperimental Treatment1 Intervention
Group III: Phase 2 Monotherapy Dose Expansion, Lung Cancer CohortExperimental Treatment1 Intervention
Group IV: Phase 2 Monotherapy Dose Expansion, Endometrial Cancer CohortExperimental Treatment1 Intervention
Group V: Phase 2 Monotherapy Dose Expansion, Breast Cancer CohortExperimental Treatment1 Intervention
Group VI: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patientsExperimental Treatment2 Interventions
Group VII: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patientsExperimental Treatment2 Interventions
Group VIII: Phase 1b Combination Therapy Dose Escalation, Part 1Experimental Treatment2 Interventions
Group IX: Phase 1 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PMV Pharmaceuticals, Inc

Lead Sponsor

Trials
6
Recruited
340+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
A systematic review of four trials involving 3425 patients found that lower doses of pembrolizumab (2 mg/kg every 3 weeks) are equally effective as higher doses (10 mg/kg) in treating advanced melanoma and non-small-cell lung cancer (NSCLC).
The safety profile of pembrolizumab was similar across different doses, suggesting that the lower dose may be sufficient for routine treatment without compromising efficacy.
Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review.Abdel-Rahman, O.[2018]

Citations

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. [2018]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Pembrolizumab: first global approval. [2021]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]
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