PM54 + Pembrolizumab for Cancer
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Dose Expansion
Participants will receive the recommended dose of PM54 in combination with pembrolizumab as observed in Part 1 of the study.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive recommended dose of PM54 in combination with pembrolizumab as observed in Part 1 of the study.
Participants will initially receive a low dose of PM54. If the low dose level is tolerated, PM54 will be escalated to the high dose level in combination with pembrolizumab until a suitable dose of PM54 is established or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PharmaMar
Lead Sponsor
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
5.
clinicaltrials.eu
clinicaltrials.eu/trial/a-study-of-pm54-and-pembrolizumab-in-adults-with-advanced-cancer/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 ...
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