119 Participants NeededMy employer runs this trial

PM54 + Pembrolizumab for Cancer

Recruiting at 10 trial locations
CF
Overseen ByCristian Fernandez, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment that combines PM54 (an experimental treatment) with pembrolizumab. The goal is to determine the optimal dose and evaluate how effectively the combination works against tumors. Researchers aim to ensure safety and assess its ability to slow or stop cancer growth. Suitable candidates for this trial have advanced cancer that hasn't responded to other treatments and continues to progress despite previous therapies. The trial begins with low doses to monitor safety before increasing to higher doses. Participants will have their response to the treatment closely monitored throughout the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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

The trial protocol does not specify if you must stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) for some treatments, like chemotherapy and certain targeted agents, before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown pembrolizumab to be safe and generally well-tolerated by many patients, including those previously treated for aggressive lung cancer. Specifically, research indicates that pembrolizumab has been safely used in advanced non-small cell lung cancer (NSCLC) and has provided benefits without major safety issues.

However, safety warnings have emerged when pembrolizumab is combined with other treatments. Some studies reported more deaths in groups receiving pembrolizumab with other drugs. It is important to note that this may not relate to the combination with PM54, as this specific combination is still under investigation for safety and effectiveness.

The combination of PM54 and pembrolizumab is currently being tested in an early-stage trial (Phase 1/Phase 2) to assess its safety and determine the appropriate dose. This phase involves closely monitoring for any unwanted effects. While pembrolizumab alone has a history of being well-tolerated, the combination with PM54 is still under study to ensure its safety for participants.12345

Why are researchers excited about this trial's treatments?

Most treatments for cancer, like chemotherapy and radiation, work by killing rapidly dividing cells, which can harm healthy cells too. But PM54, in combination with pembrolizumab, offers a fresh approach. Pembrolizumab is already known for its immune-boosting effects, helping the body's own defenses target cancer cells. The excitement around PM54 lies in its potential to enhance this immune response even further by modulating specific pathways, possibly leading to more effective and targeted cancer treatment with less damage to healthy cells. Researchers are optimistic that this combination could provide a more precise attack on cancer with fewer side effects.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that pembrolizumab, a current cancer treatment, helps the immune system fight cancer cells and has effectively treated various cancers, often by shrinking tumors. In this trial, researchers are studying PM54, a new treatment, in combination with pembrolizumab. Early signs suggest PM54 might also boost the immune system against cancer. Researchers are examining how PM54 works with pembrolizumab because, together, they might improve the cancer's response to treatment and enhance patient benefits. While data on PM54 is still being gathered, the hope is that these combined treatments could provide a stronger defense against cancer.

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancers that have spread or cannot be removed by surgery. Participants should be in generally good health aside from their cancer and able to carry out daily activities.

Inclusion Criteria

Voluntarily signed and dated written informed consent before any study-specific procedures
Measurable disease according to RECIST1.1 or mRECIST v1.1 where applicable
Adequate laboratory parameters within 7 days of intervention including ANC >=1.5*10^9/L, platelets >=100*10^9/L, hemoglobin >=9 g/dL, AST and ALT <=3.0*ULN, total bilirubin <=1.0*ULN (up to 1.5*ULN for Gilbert's syndrome), creatinine clearance >=30 mL/min (Cockcroft-Gault), serum albumin >=3 g/dL without infusion, creatine kinase <=2.5*ULN
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Exclusion Criteria

History of hypersensitivity to PM54, pembrolizumab, or inactive ingredients
Detectable hepatitis C virus RNA if anti-HCV antibody positive
Positive hepatitis B surface antigen with HBV DNA >=1000 IU/mL; HBV DNA <1000 IU/mL or occult infection requires prophylaxis
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Participants will initially receive a low dose of PM54. If tolerated, PM54 will be escalated to a high dose level in combination with pembrolizumab until a suitable dose is established or until clinical or objective disease progression, withdrawal of consent, or unacceptable toxicity occurs.

up to 12 weeks

Dose Expansion

Participants will receive the recommended dose of PM54 in combination with pembrolizumab as observed in Part 1 of the study.

up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • PM54

Trial Overview

The study is testing a new drug called PM54 given together with pembrolizumab (an immunotherapy) to find the safest dose and see how well this combination works against advanced cancers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2 (Dose Expansion): PM54 + PembrolizumabExperimental Treatment2 Interventions
Group II: Part 1 (safety Run-in): PM54 + PembrolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

PharmaMar

Lead Sponsor

Trials
93
Recruited
11,800+

José María Fernández de Sousa-Faro

PharmaMar

Chief Executive Officer since 1986

PhD in Biochemistry, Complutense University of Madrid

Carmen Cuevas Marchante

PharmaMar

Chief Medical Officer since 2002

MD, University of Navarra

Citations

Study of PM54 in Combination With Immunotherapy in ...

The main purpose of the study is to evaluate the safety, tolerability and recommended dose of PM54 in combination with pembrolizumab.

Effectiveness and safety of pembrolizumab for patients ... - PMC

Several randomized controlled trials (RCTs) have confirmed the favorable clinical benefit of pembrolizumab in advanced non-small cell lung cancer (NSCLC).

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab ...

Five-year overall survival rate of 19.4% and 18.4% for KEYTRUDA plus chemotherapy. The median OS was 17.2 months for the KEYTRUDA plus chemotherapy group ...

Favorable Safety Profile Seen in Immunotherapy Drug in ...

The immunotherapy drug pembrolizumab has demonstrated a favorable safety profile and “promising durable clinical activity” in pretreated patients

A study of PM54 and pembrolizumab in adults with ...

This study is being conducted to evaluate the safety and effectiveness of combining the experimental drug PM54 with pembrolizumab in adults with advanced ...