Amivantamab + Standard Care for Head and Neck Cancer
(OrigAMI-5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding amivantamab, a targeted therapy, to a standard cancer treatment plan can more effectively combat head and neck squamous cell carcinoma, which affects areas like the mouth and throat. It compares two treatment plans: one includes amivantamab, pembrolizumab, and carboplatin, while the other includes pembrolizumab, 5-fluorouracil, and platinum therapy (such as carboplatin or cisplatin). The trial seeks participants with head and neck cancer that has recurred or spread and who have not yet received systemic treatment. Ideal candidates are those whose cancer cannot be cured with local treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that amivantamab is generally well-tolerated by patients with head and neck cancer. Tumors shrank in 82% of patients, indicating a strong response to the treatment. These studies reported no severe side effects, suggesting that amivantamab is a safe and promising treatment option.
Previous research has shown that pembrolizumab, another treatment in the study, is usually well-tolerated. Some patients might experience side effects like tiredness or nausea, but these are typically manageable.
Carboplatin, a chemotherapy drug used in this trial, is also known for its safety. It is widely used in cancer treatment, and its side effects are often predictable and manageable.
Overall, extensive studies have considered these treatments safe for patients with head and neck cancer.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the treatment combining Amivantamab and standard care for head and neck cancer because Amivantamab offers a new mechanism of action. Unlike most treatments that target the cancer indirectly, Amivantamab is a bispecific antibody that directly targets and binds to specific receptors on cancer cells, potentially leading to more effective cancer cell destruction. This approach may enhance the efficacy of existing treatments like pembrolizumab and carboplatin, offering a promising new option for patients who have not responded well to current therapies.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
In this trial, participants in Arm A will receive a combination of amivantamab, pembrolizumab, and carboplatin. A previous study showed promising results, with 45% of patients with recurrent or metastatic head and neck cancer responding to the treatment. Tumors shrank in 82% of patients, and these responses were both quick and long-lasting. On average, the positive effects lasted for 7.2 months. These findings suggest that this treatment can effectively reduce tumor size and maintain its effects over time. This evidence supports the effectiveness of the amivantamab, pembrolizumab, and carboplatin combination for people with head and neck squamous cell carcinoma who haven't received prior treatment. Meanwhile, participants in Arm B will receive pembrolizumab, 5-fluorouracil (5-FU), and carboplatin or cisplatin.13678
Who Is on the Research Team?
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 recurrent/metastatic head and neck squamous cell carcinoma that can't be cured by local treatments. Participants must have specific tumor locations (oral cavity, oropharynx, hypopharynx, larynx), no prior systemic therapy in the metastatic setting, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), measurable disease per RECIST v1.1 criteria, and be HPV-negative if the cancer is located in the oropharynx.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pembrolizumab, amivantamab, and carboplatin or pembrolizumab, 5-FU, and platinum therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 5-Fluorouracil
- Amivantamab
- Carboplatin
- Pembrolizumab
Trial Overview
The study tests amivantamab combined with pembrolizumab and carboplatin against a standard treatment of pembrolizumab with 5-fluorouracil (FU) and platinum therapy (carboplatin or cisplatin). It aims to see which combination works better for treating patients who haven't had previous systemic treatment for their advanced head and neck cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive pembrolizumab, amivantamab and carboplatin.
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
Subcutaneous amivantamab delivers promising 45 percent ...
Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study ...
2.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/rybrevant/medical-content/use-of-rybrevant-in-head-neck-cancer-origami4-studyUse of RYBREVANT in Head & Neck Cancer - OrigAMI-4 ...
A summary of data from the OrigAMI-4 study on the use of RYBREVANT® (amivantamab-vmjw) in patients with head & neck cancer.
A Study of Amivantamab in Addition to Standard of Care ...
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab ...
Subcutaneous RYBREVANT (amivantamab) delivers ...
Subcutaneous RYBREVANT (amivantamab) delivers promising 45 percent overall response rate with median duration of response of 7.2 months in ...
A study of amivantamab in addition to standard of care ...
Interventions. The purpose of this study is to compare anti-tumour activity of amivantamab in addition to pembrolizumab and carboplatin versus ...
Subcutaneous amivantamab in recurrent/metastatic head ...
Median progression-free survival was 6.8 months (95 % CI, 4.2–9.0). Subcutaneous amivantamab as second-/third-line treatment among participants with R/M HNSCC ...
7.
pharmacytimes.com
pharmacytimes.com/view/amivantamab-shows-45-response-rate-in-pretreated-head-and-neck-cancer-origami-4-findingsAmivantamab Shows 45% Response Rate in Pretreated ...
Subcutaneous amivantamab demonstrated robust activity in patients with recurrent or metastatic head and neck squamous cell carcinoma ...
Subcutaneous amivantamab delivers promising 45 percent ...
Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients. New findings from this investigational study ...
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