GME751 vs Keytruda for Melanoma

Recruiting at 75 trial locations

Overseen By Clinical Disclosure Representative

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sandoz

Must be taking: Pembrolizumab

Must not be taking: Live vaccines, Anti-PD-1 agents

Disqualifiers: Ocular melanoma, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

318 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, GME751 (an experimental treatment), against the well-known drug Keytruda for individuals with advanced melanoma, a type of skin cancer. The researchers aim to determine if GME751 is as effective and safe as Keytruda. Participants must have had their melanoma completely removed by surgery within the last 13 weeks and should be in good general health. 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 treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have an active autoimmune disease that required treatment in the last 2 years, you may not be eligible to participate.

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

Research shows that GME751, a treatment similar to Keytruda, is under study for its safety in treating melanoma and other cancers, such as non-small cell lung cancer. This treatment is designed to function like Keytruda. Studies are testing GME751 to ensure it is as safe and effective as Keytruda.

Keytruda is already approved for treating melanoma, and its safety is well-known. It is widely used and generally well-tolerated, though, like all medications, it can have side effects.

Current research on GME751 is in an early stage, focusing on how the treatment works in the body and its safety. Researchers are closely monitoring for any side effects or adverse reactions. This step is crucial to ensure the treatment is safe for broader use.

Prospective trial participants should know that researchers prioritize understanding the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about GME751 for melanoma because it offers a potential new approach compared to the current standard treatments like Keytruda. Unlike existing options that generally focus on blocking specific proteins to boost the immune system, GME751 might have a novel mechanism of action or a unique molecular structure that enhances its effectiveness. This could mean better targeting of melanoma cells or improved patient outcomes. These features make GME751 a promising candidate, sparking interest in its ability to provide a more effective or faster-acting treatment for this challenging condition.

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

Research shows that Keytruda, also known as pembrolizumab, effectively treats advanced melanoma. It can extend patients' lives and shrink tumors. After 10 years, more than one-third of patients with advanced melanoma remained alive after using Keytruda. In this trial, participants will receive either Keytruda or GME751. The researchers are studying GME751 to determine if it works like Keytruda. The study focuses on how GME751 is absorbed by the body, its safety, and its ability to activate the immune system. Early results are promising, but more information is needed. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults diagnosed with advanced melanoma that's been surgically removed within the past 13 weeks can join. They should be in good health with a performance status of 0 or 1, indicating they're fully active or have some symptoms but don't need bed rest. People with eye-related melanoma, severe allergies to pembrolizumab, autoimmune diseases, recent live vaccines, or prior treatments targeting T cell receptors cannot participate.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

My organs are working well.

I have been diagnosed with advanced melanoma.

Exclusion Criteria

I have a history of eye melanoma.

Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients

I have not received a live vaccine in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either GME751, Keytruda-US, or Keytruda-EU for 24 weeks in 4 treatment cycles, each of 6 weeks duration

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants benefiting from treatment without signs of recurrence or unacceptable toxicity may continue pembrolizumab treatment based on country regulations

What Are the Treatments Tested in This Trial?

Interventions

• GME751
• Keytruda

Trial Overview The trial is testing GME751 against US-licensed and EU-authorized Keytruda (both forms of pembrolizumab) for their effects on drug levels in the body and overall safety and effectiveness in preventing melanoma from returning after surgery.

How Is the Trial Designed?

Group I: GME751 Experimental Treatment 1 Intervention

Subjects will receive GME751 via intravenous (IV) infusion.

Group II: Keytruda - US Active Control 1 Intervention

Subjects will receive Keytruda-US via intravenous (IV) infusion.

Group III: Keytruda - EU Active Control 1 Intervention

Subjects will receive Keytruda-EU via intravenous (IV) infusion.

Who Is Running the Clinical Trial?

Sandoz

Lead Sponsor

Trials

145

Recruited

26,800+

Dr. David Chang

Sandoz

Chief Medical Officer

MD from Albert Einstein College of Medicine

Richard Saynor

Sandoz

Chief Executive Officer since 2019

Bachelor of Pharmacy from the University of Bradford

Published Research Related to This Trial

In a meta-analysis of 15 studies involving cancer patients treated with either nivolumab or pembrolizumab, nivolumab was associated with a higher overall incidence of cardiotoxicity (55.7%) compared to pembrolizumab (27.31%), although this difference was not statistically significant.

However, when looking specifically at myocarditis, pembrolizumab showed a significant increase in cardiotoxicity risk, suggesting that while nivolumab may be more commonly reported for general cardiotoxicity, pembrolizumab poses a greater risk for this specific heart condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiotoxicity risk of pembrolizumab versus nivolumab in cancer patients undergoing immune checkpoint inhibitor therapy: A meta-analysis. Ndjana Lessomo, FY., Wang, Z., Mukuka, C.[2023]

Nivolumab combined with ipilimumab demonstrated significantly better overall survival compared to BRAF + MEK inhibitors, with hazard ratios indicating a 36% to 44% reduction in the risk of death after 12 months.

While nivolumab + ipilimumab had improved survival outcomes, it also resulted in a higher rate of grade 3/4 adverse events (54.1%) compared to dabrafenib + trametinib (31.6%) and similar rates to vemurafenib + cobimetinib (59.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of combination immunotherapy and targeted therapy in the treatment of BRAF-mutant advanced melanoma: a matching-adjusted indirect comparison. Atkins, MB., Tarhini, A., Rael, M., et al.[2020]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.

Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. Barone, A., Hazarika, M., Theoret, MR., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

In the phase III CheckMate 238 trial, 67.7% of patients receiving nivolumab experienced treatment-related adverse events (TRAEs), with the most common being pruritus and diarrhea, primarily occurring within the first 3 months of treatment.

Despite the high incidence of TRAEs, there was no significant association found between these adverse events and recurrence-free survival (RFS), indicating that the safety profile of nivolumab remains consistent and does not negatively impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. Mandala, M., Larkin, J., Ascierto, PA., et al.[2022]

Pembrolizumab (Keytruda) is an effective treatment for advanced melanoma, showing significant improvements in progression-free survival and overall response rates compared to ipilimumab and chemotherapy in clinical trials involving patients with varying treatment histories.

The drug has a manageable safety profile, with immune-related side effects that are generally reversible, making it a valuable option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: A Review in Advanced Melanoma. Deeks, ED.[2022]

Pembrolizumab (Keytruda) is an approved treatment for metastatic or locally advanced esophageal and gastroesophageal junction cancer, indicating its efficacy in targeting these specific cancer types.

It is used in combination with platinum- and fluoropyrimidine-based chemotherapy, suggesting a synergistic approach to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. Aschenbrenner, DS.[2023]

In a study of 576 patients with advanced melanoma receiving nivolumab, 71% experienced treatment-related adverse events (AEs), primarily low-grade, with fatigue, pruritus, diarrhea, and rash being the most common, and no drug-related deaths reported.

Patients who experienced any grade of treatment-related select AEs had a significantly higher objective response rate (ORR), indicating a potential link between these AEs and improved treatment efficacy, although the use of immune-modulating agents to manage AEs did not impact ORR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Weber, JS., Hodi, FS., Wolchok, JD., et al.[2022]

In a study of 168 patients with advanced melanoma treated with pembrolizumab in community oncology settings, the median overall survival was 19.4 months, indicating its effectiveness in real-world scenarios.

Treatment-related toxicity led to discontinuation in 25% of patients, highlighting the importance of monitoring side effects, although the safety profile of pembrolizumab aligns with clinical trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Utilization and Outcomes for Advanced Melanoma in US Community Oncology Practices. Cowey, CL., Liu, FX., Black-Shinn, J., et al.[2021]

In a study of 655 patients with advanced melanoma, pembrolizumab showed a 5-year overall survival rate of 34%, with even better outcomes (41%) for treatment-naive patients, indicating its long-term efficacy.

The treatment was generally well-tolerated, with 86% of patients experiencing treatment-related adverse events, but only 7.8% discontinued due to these effects, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Hamid, O., Robert, C., Daud, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06153238

NCT06153238 | A PK Study to Compare GME751 ... The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® ( ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/470900

A PK Study to Compare GME751 (Proposed ... The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared ...

3. withpower.com withpower.com/trial/phase-1-melanoma-1-2024-26354

GME751 vs Keytruda for Melanoma Keytruda (pembrolizumab) has been shown to be effective in treating advanced melanoma, with studies indicating it can improve survival rates and reduce tumor ...

4. merck.com merck.com/news/ten-year-data-for-mercks-keytruda-pembrolizumab-demonstrates-sustained-overall-survival-benefit-versus-ipilimumab-in-advanced-melanoma/

Ten-Year Data for Merck's KEYTRUDA® (pembrolizumab ... At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454464/

Real-World Outcomes of Pembrolizumab in Advanced ... Real-world Australian data indicate pembrolizumab monotherapy for advanced melanoma achieves survival outcomes consistent with clinical trials, ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-of-continued-treatment-with-gme751-pembrolizumab-biosimilar-for-patients-with-melanoma-or-non-small-cell-lung-cancer/

Study on the Safety of Continued Treatment with GME751 ... This clinical trial investigates the safety of continued treatment with GME751, a pembrolizumab biosimilar, for patients with melanoma and non-small cell ...

7. ucihealth.org ucihealth.org/clinical-trials/uci-23-220

Study Description The purpose of the study is to demonstrate similarity of PK between the proposed pembrolizumab biosimilar GME751, Keytruda-EU and Keytruda-US in ...