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Taking people in United StatesPhase 1/2

Tests amivantamab alone or with other drugs in head and neck cancer

Tests amivantamab, alone or with other drugs, in adults with head and neck cancer.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Ann Arbor, Aurora, Baltimore, Boston, Chapel Hill, Charlottesville, Chicago, Cleveland, Detroit, Fairfax, La Jolla, New Brunswick, New Haven, Salt Lake City, and St Louis, United StatesSee the 15 sitesAlso in 10 other countries, 41 sites
Registry title
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Status
Recruiting
Phase
Phase 1/2
People taking part
287 people, planned
Started
22 Apr 2024
Expected to end
28 Jul 2033
Type of study
Interventional, 7 groups
Treatments tested
  • Amivantamab
  • Pembrolizumab
  • Paclitaxel
  • Carboplatin
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with head and neck squamous cell cancer that came back or spread, or that is advanced but can be removed by surgery. It tests amivantamab alone or with other cancer drugs.

Age
18 years or older
Sex
All sexes can join
Disease stage
Head and neck squamous cell cancer that came back or spread and cannot be cured with local treatment (cohorts 1 to 5), or Stage III or IVa cancer that can be removed by surgery (cohort 6). Tumors in the oropharynx, oral cavity, hypopharynx or larynx. Measurable or evaluable disease. ECOG performance status 0 to 1.
Earlier treatment
Side effects from earlier cancer treatment must have settled to Grade 1 or less (cohorts 1 to 5). A gap of 2 weeks or 4 half-lives, whichever is longer, is needed after earlier chemotherapy, targeted therapy, immunotherapy or investigational cancer drug; the longest required gap is 28 days. A gap of 7 days is needed after radiotherapy given for symptom relief.
Biomarker or test result
Known p16 status must be negative for cohorts 1, 2, 3A, 3B and 6. Cohort 4 needs an HPV-positive oropharynx tumor (positive p16 test or high-risk HPV ISH). Cohort 5 needs known HPV status for oropharynx tumors. PD-L1 test results from the local lab must be provided where available (cohort 5: must be provided).

Main reasons for not taking part

  • Current or past interstitial lung disease, pneumonitis or pulmonary fibrosis
  • Untreated brain metastases, leptomeningeal disease or spinal cord compression not fully treated with surgery or radiation
  • History of clinically significant cardiovascular disease
  • Cancer treatment too recently, before the first dose (see washout times)
  • Palliative radiotherapy within 7 days of the first dose

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease
  • Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1
  • Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone replacement)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test; Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils >=1.5 x 10\^3/mcg; c) Platelets >=100 x 10\^3/mcg

Who cannot take part

  • Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
  • Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
  • Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
  • Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  • Participant with a history of clinically significant cardiovascular disease

Where in United States

Also in 10 other countries, 41 sites

  • University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
  • University of Colorado Denver Anschultz Medical CampusAurora, United StatesTaking people
  • University of Maryland School of MedicineBaltimore, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
  • University of VirginiaCharlottesville, United StatesTaking people
  • The University of Chicago Medical Center (UCMC)Chicago, United StatesTaking people
  • Cleveland ClinicCleveland, United StatesTaking people
  • Karmanos Cancer InstituteDetroit, United StatesTaking people
  • Virginia Cancer SpecialistsFairfax, United StatesTaking people
  • University of California at San Diego - Moores Cancer CenterLa Jolla, United StatesNo longer taking part
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
  • Yale Cancer CenterNew Haven, United StatesTaking people
  • University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
  • Washington University School of MedicineSt Louis, United StatesTaking people

About the trial

What the trial wants to find out

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

The 7 groups in the trial

  • Cohort 1: Amivantamab Monotherapy (Dose Expansion)Treatment being tested

    Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \>=80 kilograms \[kg\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.

    Treatment: Amivantamab

  • Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)Treatment being tested

    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).

    Treatment: Amivantamab and Pembrolizumab

  • Cohort 3A (Dose Confirmation): Amivantamab + PaclitaxelTreatment being tested

    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.

    Treatment: Amivantamab and Paclitaxel

  • Cohort 3B (Dose Expansion): Amivantamab + PaclitaxelTreatment being tested

    Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.

    Treatment: Amivantamab and Paclitaxel

  • Cohort 4: Amivantamab MonotherapyTreatment being tested

    Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards.

    Treatment: Amivantamab

  • Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)Treatment being tested

    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve \[AUC\] 5 milligram per milliliter \[mg/ml\]\*min) q3w on Day 1 of Cycles 1-6.

    Treatment: Amivantamab, Pembrolizumab, and Carboplatin

  • Cohort 6: Amivantamab + PembrolizumabTreatment being tested

    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for \>80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1.

    Treatment: Amivantamab and Pembrolizumab

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma
Plain-language title
Tests amivantamab alone or with other drugs in head and neck cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
3 November 2026