Pembrolizumab + Odetiglucan for Colorectal Cancer

Overseen By William Chapin, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Active infection, Autoimmune disease, Cardiovascular disease, CNS metastases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, pembrolizumab (an immunotherapy drug) and odetiglucan (an experimental treatment), to determine their safety and effectiveness in treating colorectal cancer that has primarily spread to the liver. It targets patients who have already tried other common treatments but need more options. Individuals with colorectal cancer and liver tumors who have previously used certain chemotherapy drugs might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received certain cancer treatments or investigational drugs recently, and you should not be on high doses of steroids or immunosuppressive therapy before starting the trial.

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

Research shows that combining pembrolizumab with odetiglucan is generally safe and well-tolerated. The FDA has approved pembrolizumab for treating other types of cancer, and past studies have proven its effectiveness and safety. In one study, patients who received pembrolizumab lived longer than those who underwent chemotherapy. Adding odetiglucan to pembrolizumab has also been found to be safe. Reports indicate that this combination is tolerable, although it did not significantly improve results in some cases. Overall, previous research suggests that this treatment combination has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pembrolizumab and Odetiglucan for colorectal cancer because they bring a fresh approach to treatment. Pembrolizumab is an immunotherapy that boosts the body's immune response to fight cancer cells, a different strategy compared to traditional chemotherapy like FOLFOX or FOLFIRI. Odetiglucan is an innovative agent that enhances the immune system's recognition and attack on cancer cells. This combo could potentially improve outcomes by making the immune system more effective against tumors, offering hope for better results than existing treatments.

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

Research has shown that pembrolizumab, when used alone, tends to cause fewer serious side effects than standard chemotherapy for colorectal cancer, potentially making it easier for patients to tolerate. This trial examines the combination of pembrolizumab and odetiglucan to determine if it enhances treatment effectiveness, particularly for cancer that has spread to the liver. Although limited data exists on the efficacy of this combination, the goal is to assess whether odetiglucan can enhance the immune system's ability to fight cancer cells. Early results from using both treatments together are promising and aim to improve patient outcomes compared to current therapies. ^{1 2 3 6 7}

Who Is on the Research Team?

William Chapin, MD, MSCE

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

This trial is for patients with metastatic colorectal cancer that has spread mainly to the liver. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may have to meet certain health standards.

Inclusion Criteria

Participant provides written informed consent

Have a life expectancy of 3 months or greater

I am 18 or older with a confirmed diagnosis of metastatic colorectal cancer mainly affecting my liver.

Exclusion Criteria

Positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication

Received investigational agent or used investigational device within specified timeframes

Severe hypersensitivity to pembrolizumab and/or any of its excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and odetiglucan for metastatic colorectal cancer

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Odetiglucan
• Pembrolizumab

Trial Overview The study is testing the safety and effectiveness of combining two drugs: Pembrolizumab, an immunotherapy drug, and Odetiglucan, which may help the immune system fight cancer. The goal is to see if this combination works better for liver-dominant metastatic colorectal cancer.

How Is the Trial Designed?

Group I: Pembrolizumab and Odetiglucan Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07082439

NCT07082439 | Pembrolizumab and Odetiglucan in Liver ... This study will evaluate the safety and effectiveness of the combination of pembrolizumab and odetiglucan in patients with metastatic colorectal cancer ...

2. patlynk.com patlynk.com/trial/NCT07082439

Pembrolizumab and Odetiglucan for Liver-Predominant ... The study aims to test the safety and effectiveness of combining two drugs, pembrolizumab and odetiglucan, to see if they can work together to better treat this ...

3. withpower.com withpower.com/trial/phase-2-colorectal-adenocarcinoma-metastatic-in-the-liver-6-2025-b2a26

Pembrolizumab + Odetiglucan for Colorectal Cancer This study will evaluate the safety and effectiveness of the combination of pembrolizumab and odetiglucan in patients with metastatic colorectal cancer that is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043776/

Emerging evidence of immunotherapy for colorectal cancer In addition, the frequency of grade 3 or higher adverse events was lower in the pembrolizumab group compared to standard chemotherapy (56% vs 78%). The results ...

5. sigma.larvol.com sigma.larvol.com/company.php?CompanyId=854159&tab=newstrac

HiberCell News The addition of imprime to Pembro did not improve outcomes in the phase II portion; however, many of the participants had ICI as their prior line of therapy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39631622/

5-year follow-up from the randomized phase III KEYNOTE ... Median OS was more than twice as long in patients treated with pembrolizumab versus chemotherapy in first line despite an effective crossover rate of 62%.

7. synapse.patsnap.com synapse.patsnap.com/drug/b3cffc1fb3a54fd397d0c976788ea8e5

Odetiglucan - Drug Targets, Indications, Patents Overall, the combination was safe and tolerable. Conclusions: The combination of imprime and pembrolizumab is tolerable but did not improve the outcome of ...