Amivantamab + Chemotherapy for Head and Neck Cancer
(CAPT-HN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for head and neck cancer that has returned or spread. Researchers are testing the effectiveness of a drug called amivantamab, a monoclonal antibody, alongside chemotherapy. The goal is to determine if this combination can benefit patients who have not responded to other treatments. The trial seeks participants with a specific type of head and neck cancer who have already tried therapies such as immunotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that amivantamab, when combined with paclitaxel, has been tested in people with head and neck cancer. The safety profile of this treatment aligns with earlier studies, revealing no new safety concerns. Dr. Ranee Mehra noted that the side effects matched expectations for this type of treatment, deeming it safe for patients with recurring or spreading head and neck squamous cell carcinoma (HNSCC).
In other studies, combining amivantamab with pembrolizumab (another cancer treatment) proved both effective and safe for patients. Overall, these findings suggest that amivantamab is well-tolerated with known side effects, making it a promising option for treating this type of cancer.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for head and neck cancer, which typically involve chemotherapy drugs like cisplatin and fluorouracil, Amivantamab is unique because it combines with chemotherapy in a new way. It targets specific proteins on cancer cells, making it potentially more effective at halting tumor growth and spread. Researchers are excited about Amivantamab because it offers a novel approach by combining targeted therapy with traditional chemotherapy, potentially leading to better outcomes for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This combination might enhance the effectiveness of chemotherapy while minimizing some of its traditional side effects.
What evidence suggests that Amivantamab might be an effective treatment for head and neck cancer?
Studies have shown that amivantamab yields promising results for treating head and neck cancer that has spread or returned. In research involving patients with this type of cancer, amivantamab shrank tumors in 45% of the patients, meaning almost half saw their tumors reduce in size. The treatment also allowed patients to live for nearly 7 months on average without their cancer worsening. Additionally, 74% of patients experienced positive effects, such as tumor shrinkage or disease stabilization. These results suggest amivantamab could be a promising option for this challenging condition. Participants in this trial will receive a combination of Carboplatin, Paclitaxel, and Amivantamab hyaluronidase to evaluate its effectiveness in treating unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).46789
Who Is on the Research Team?
Paul Swiecicki, MD
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of Carboplatin, Paclitaxel, and Amivantamab hyaluronidase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Carboplatin + Paclitaxel + Amivantamab hyaluronidase
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Janssen Medical Affairs
Industry Sponsor
SWOG Clinical Trials Partnerships, LLC
Collaborator
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 ...
Preliminary results from the phase 1b/2 OrigAMI-4 study
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 ...
3.
onclive.com
onclive.com/view/dr-mehra-on-the-efficacy-of-subcutaneous-amivantamab-plus-pembrolizumab-in-hnsccDr Mehra on the Efficacy of Subcutaneous Amivantamab ...
She noted that initial data from cohort 1 of OrigAMI-4 presented at the 2025 ESMO Congress showed an overall response rate (ORR) of 45% (95% CI, ...
4.
jnjmedicalconnect.com
jnjmedicalconnect.com/media/attestation/congresses/oncology/2025/esmo/amivantamab-in-recurrent-metastatic-head-and-neck-squamous-cell-cancer-hnscc-after-disease-progressi.pdfamivantamab-in-recurrent-metastatic-head-and-neck- ...
aAs of data cutoff, 38 participants had ≥2 disease assessments (or discontinued for any reason) and were included in the efficacy analysis.
5.
cancernetwork.com
cancernetwork.com/view/subcutaneous-amivantamab-earns-breakthrough-therapy-designation-in-hnsccSubcutaneous Amivantamab Earns Breakthrough Therapy ...
Among 38 efficacy-evaluable patients treated with subcutaneous amivantamab, an overall response rate (ORR) of 45% (95% CI, 29%-62%) was observed ...
RYBREVANT FASPRO™ (amivantamab and ...
Ten percent complete response and rapid, durable antitumor activity reported with RYBREVANT FASPRO™; results surpass current standards of ...
7.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/rybrevant-faspro/medical-content/use-of-rybrevant-faspro-in-head-neck-cancer-origami4-studyUse of RYBREVANT FASPRO in Head & Neck Cancer
Safety data are included in Table: Safety Profile for the Amivantamab SC plus Paclitaxel Combination Cohort 3a. Safety Profile for the ...
RYBREVANT FASPRO™ (amivantamab and ...
Ten percent complete response and rapid, durable antitumor activity reported with RYBREVANT FASPRO™; results surpass current standards of ...
9.
cancernetwork.com
cancernetwork.com/view/subcutaneous-amivantamab-displays-activity-in-recurrent-metastatic-hnsccSubcutaneous Amivantamab Displays Activity in Recurrent ...
The safety profile of amivantamab was consistent with previous reports in this HNSCC population, with no new signals reported.
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