34 Participants Needed

CYAD-101 + Chemotherapy and Immunotherapy for Colorectal Cancer

Recruiting at 5 trial locations
CO
Overseen ByCelyad Oncology Medical Monitor, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Celyad Oncology SA
Must be taking: FOLFOX chemotherapy
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?

The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer agents and investigational agents at least 4 weeks before starting the study treatment. You also need to avoid certain growth factors and radiotherapy shortly before the trial begins. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

Is the combination of CYAD-101, chemotherapy, and immunotherapy generally safe for humans?

The combination of immune checkpoint inhibitors (like Pembrolizumab) and chemotherapy can lead to more gastrointestinal side effects, such as diarrhea and colitis (inflammation of the colon), compared to chemotherapy alone. These side effects can vary depending on the specific drugs used in the treatment.12345

What makes the treatment CYAD-101 unique for colorectal cancer?

CYAD-101 is unique because it combines chemotherapy and immunotherapy, aiming to enhance the body's immune response against colorectal cancer, which is typically resistant to immunotherapy alone. This approach is still experimental, as immunotherapy has not yet become a standard treatment for most colorectal cancer cases.678910

What data supports the effectiveness of the drug CYAD-101 + Chemotherapy and Immunotherapy for Colorectal Cancer?

Immunotherapy, which is part of this treatment, has shown potential benefits in colorectal cancer, especially in patients with certain genetic markers (MSI-H). Additionally, chemotherapy regimens like FOLFOX are standard treatments for stage III colon cancer, known to reduce recurrence and improve survival.69111213

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colorectal cancer that's not been surgically removed and doesn't respond to standard treatments. Participants must have had FOLFOX chemotherapy, be in good physical condition (ECOG 0 or 1), and have tumors measurable by RECIST criteria. They can't join if they've used certain growth factors, had major surgery, uncontrolled illnesses, live vaccines, anticancer agents or radiotherapy recently; or if they've ever received drugs like Pembrolizumab before.

Inclusion Criteria

My tumor does not have high microsatellite instability.
My cancer is a type of colon or rectal cancer that has spread.
Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
See 7 more

Exclusion Criteria

I have been treated with specific immune therapy drugs before.
I have or had lung inflammation that needed steroids, confirmed by recent chest imaging.
I have not had radiotherapy in the last 2 weeks.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CYAD-101 is administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment

13 weeks
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CYAD-101
  • FOLFOX
  • Pembrolizumab
Trial Overview The study tests CYAD-101 cells given with FOLFOX chemo followed by Pembrolizumab immunotherapy in patients with advanced colorectal cancer. It aims to see how safe this combination is and whether it works against the cancer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumabExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celyad Oncology SA

Lead Sponsor

Trials
13
Recruited
1,300+

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

Adjuvant therapy using 5-fluorouracil and levamisole for node-positive colon cancer, and chemoradiotherapy with 5-fluorouracil and high-dose radiotherapy for stage II or III rectal cancer, significantly reduces recurrence and mortality, improving overall survival by over 30%.
Ongoing trials are exploring various combinations and durations of chemotherapy and radiotherapy, as well as the potential of aspirin for colon cancer prevention, indicating a shift towards more personalized and effective treatment strategies for colorectal adenocarcinoma.
Adjuvant treatment of colorectal adenocarcinoma.Steele, G., Posner, MR.[2018]
Supplementing mice with Lactobacillus rhamnosus GG (LGG) significantly increased CD8 T-cell responses in the gut, which is crucial for enhancing antitumor immune responses.
LGG administration led to a reduction in tumor burden in murine models of intestinal cancer, demonstrating its potential to improve the effectiveness of immunotherapy in colorectal cancer patients.
Lactobacillus rhamnosus GG Orchestrates an Antitumor Immune Response.Owens, JA., Saeedi, BJ., Naudin, CR., et al.[2022]
Immunotherapy for colorectal cancer has shown potential benefits in some clinical trials, but it is still considered an experimental treatment rather than a standard option.
The review discusses various immunotherapeutic strategies, such as cancer vaccines and adoptive cell therapy, highlighting their strengths and weaknesses, and aims to guide future research towards the approval and use of these therapies in clinical practice.
Colorectal cancer immunotherapy.Xiang, B., Snook, AE., Magee, MS., et al.[2022]

Citations

Adjuvant treatment of colorectal adenocarcinoma. [2018]
Lactobacillus rhamnosus GG Orchestrates an Antitumor Immune Response. [2022]
Colorectal cancer immunotherapy. [2022]
An Expanding Role for Immunotherapy in Colorectal Cancer. [2022]
Adjuvant therapy of stage III colon cancer. [2015]
Factors affecting tumor responders and predictive biomarkers of toxicities in cancer patients treated with immune checkpoint inhibitors. [2021]
Prospective evaluation of acute toxicity and patient reported outcomes in anal cancer and plan optimization. [2019]
Risk of Gastrointestinal Adverse Events in Cancer Patients Treated With Immune Checkpoint Inhibitor Plus Chemotherapy: A Systematic Review and Meta-Analysis. [2020]
Phase II study of acivicin as a 72-hr continuous infusion in patients with untreated colorectal cancer. A National Cancer Institute of Canada Clinical Trials Group Study. [2019]
Safety evaluation of oral fluoropyrimidine S-1 for short- and long-term delivery in advanced gastric cancer: analysis of 3,758 patients. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
A safety and feasibility study of an allogeneic colon cancer cell vaccine administered with a granulocyte-macrophage colony stimulating factor-producing bystander cell line in patients with metastatic colorectal cancer. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Immunotherapy in colorectal cancer: Available clinical evidence, challenges and novel approaches. [2020]
Current concepts in immunotherapy for the treatment of colorectal cancer. [2019]
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