225 Participants Needed

Amivantamab + Chemotherapy for Colorectal Cancer

(OrigAMI-1 Trial)

Recruiting at 93 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Janssen Research & Development, LLC
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?

This trial is testing a new medicine called amivantamab on patients with advanced colorectal cancer. The medicine helps the immune system find and destroy cancer cells. Researchers want to see how well it works alone and with standard chemotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the combination of Amivantamab and chemotherapy safe for treating colorectal cancer?

The safety of chemotherapy combinations like 5-fluorouracil (5-FU), leucovorin, irinotecan, and oxaliplatin has been studied in colorectal cancer, showing they are generally safe with manageable side effects. However, specific safety data for Amivantamab combined with these chemotherapies in colorectal cancer is not provided in the available research.12345

What makes the drug Amivantamab + Chemotherapy unique for colorectal cancer?

This treatment combines Amivantamab, a novel drug targeting specific cancer cell pathways, with established chemotherapy agents like Fluorouracil, Irinotecan, Leucovorin, and Oxaliplatin, which are standard in colorectal cancer treatment. The inclusion of Amivantamab, which is not typically used for colorectal cancer, may offer a new approach by potentially enhancing the effectiveness of the chemotherapy regimen.678910

What data supports the effectiveness of the drug combination Amivantamab + Chemotherapy for Colorectal Cancer?

Research shows that combinations of chemotherapy drugs like fluorouracil (5-FU), leucovorin, oxaliplatin, and irinotecan have improved survival rates in colorectal cancer patients. These combinations are standard treatments and have shown to be effective in both early and advanced stages of the disease.3791112

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced colorectal cancer that can't be removed by surgery or has spread. They must have a specific performance status, agree to a tumor biopsy, and not be pregnant. People with certain genetic mutations or brain metastasis are excluded.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
I have been diagnosed with a type of colon or rectal cancer that cannot be removed by surgery.
I am not pregnant, breastfeeding, or planning to become pregnant and agree to regular pregnancy tests.
See 2 more

Exclusion Criteria

Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
My cancer has a specific mutation identified through a blood test.
I have a history of cancer spreading to the lining of my brain and spinal cord.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive amivantamab monotherapy or in combination with standard-of-care chemotherapy in 28-day cycles

Variable, up to 4 years 3 months
Multiple visits per cycle, including Days -1, -2, 1, 8, 15, and 22

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Amivantamab
  • Fluorouracil
  • Irinotecan
  • Leucovorin
  • Oxaliplatin
Trial Overview The study tests amivantamab alone and alongside standard chemotherapy (Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan) in patients with metastatic colorectal cancer. It aims to find the safest dose when combined with chemo and measure its effectiveness against tumors.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohorts A, B, and C: Amivantamab MonotherapyExperimental Treatment1 Intervention
Group II: Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)Active Control4 Interventions
Group III: Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)Active Control4 Interventions

Amivantamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Rybrevant for:
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Approved in European Union as Rybrevant for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Adjuvant therapy with 5-fluorouracil and levamisole has been established as a standard treatment for patients with resected lymph node-positive colon cancer (stage 3), significantly improving survival rates.
Preliminary results suggest that combining 5-fluorouracil with leucovorin may reduce disease relapse in advanced cases, while ongoing research aims to enhance treatment efficacy and minimize side effects through new therapies and better understanding of cancer biology.
Role of adjuvant therapy in surgically resected colorectal carcinoma.Sinicrope, FA., Sugarman, SM.[2019]
Adjuvant therapy using 5-fluorouracil/leucovorin (5-FU/LV) regimens and capecitabine has significantly improved 3-year disease-free survival rates in stage III colorectal cancer patients, indicating its efficacy in early disease stages.
The addition of oxaliplatin to 5-FU-based regimens has been confirmed to enhance disease-free survival, establishing it as a standard treatment alongside other chemotherapy options for colorectal cancer.
Rapid evolution in colorectal cancer: therapy now and over the next five years.de Gramont, A.[2007]
The combination of fluorouracil (5-FU)/leucovorin and irinotecan (CPT-11) has significantly improved response rates and survival times for patients with metastatic colorectal cancer, making it a recommended first-line treatment.
Ongoing randomized phase III trials in Europe are investigating the efficacy of this combination as adjuvant chemotherapy for patients with stage II or III colorectal cancer, aiming to enhance cure rates in those with resected, locally advanced, nonmetastatic disease.
Update on European adjuvant trials with irinotecan for colorectal cancer.Douillard, JY., Barbarot, V., Bennouna, J.[2018]

Citations

Role of adjuvant therapy in surgically resected colorectal carcinoma. [2019]
Rapid evolution in colorectal cancer: therapy now and over the next five years. [2007]
Update on European adjuvant trials with irinotecan for colorectal cancer. [2018]
FOLFOXIRI plus biologics in advanced colorectal cancer. [2020]
Seeing the forest through the trees: a systematic review of the safety and efficacy of combination chemotherapies used in the treatment of metastatic colorectal cancer. [2018]
Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study. [2020]
The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study. [2021]
Efficacy and safety of addition of bevacizumab to FOLFIRI or irinotecan/bolus 5-FU/LV (IFL) in patients with metastatic colorectal cancer: A meta-analysis. [2022]
Cetuximab plus XELIRI or XELOX for first-line therapy of metastatic colorectal cancer. [2018]
[Systemic treatment of colorectal cancers--factual standards and perspectives]. [2018]
[Controversy of treatment for advanced colorectal cancer--intermedisine]. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
European experience with irinotecan plus fluorouracil/folinic acid or mitomycin. [2018]
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