> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-amivantamab-alone-or-in-addition-to-other-da2effdd-18c5-41c5-b5b5-9e54a87473b9 > Record changed: 2026-11-04 # A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer NCT06385080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Participants 287 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Start date 2024-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) Number of sites 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Acronym** OrigAMI-4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Short title** A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Dates **Completion date** 2033-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **First posted** 2024-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Registry last updated** 2026-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Primary completion date** 2032-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Start date** 2024-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Size and sites **Participants** 287 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Planned participants** 287 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Number of sites** 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Identifiers **Registry ID** NCT06385080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **ClinicalTrials.gov ID** NCT06385080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Outcomes ### Primary outcomes 1. Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate Timeframe: 2 years and 2 months ORR is defined as the proportion of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1. 2. Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT) Timeframe: Up to 21 days Number of participants with DLTs will be reported. A DLT is defined as any of the following: treatment delay of greater than (\\>) 28 days due to unresolved toxicity, non-hematologic toxicity of Grade 3 or higher, hematologic toxicity of Grade 4 neutropenia persisting for \\>7 days or Grade 3 or higher thrombocytopenia with clinically significant bleeding or neutropenic fever of any grade, and liver enzyme elevation. 3. Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity Timeframe: 2 years and 1 month An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0\. Severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. 4. Cohort 6: Major Pathologic Response (MPR) Timeframe: 2 years and 2 months The participants who achieve MPR at the time of surgery. ### Secondary outcomes 1. Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR) Timeframe: 2 years and 2 months DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR. 2. Cohorts 1, 2, 3B, 4 and 5: Clinical Benefit Rate (CBR) Timeframe: 2 years and 2 months CBR is defined as the percentage of participants achieving a confirmed complete or partial response, or durable stable disease (the second disease assessment) as defined by RECIST version 1.1. 3. Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS) Timeframe: 2 years and 2 months PFS is defined as the time from the first administration of study treatment until the date of objective disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. 4. Cohorts 1, 2, 3B, 4, 5 and 6: Overall Survival (OS) Timeframe: 2 years and 2 months OS is defined as the time from the first administration of study treatment until the date of death due to any cause. 5. Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity Timeframe: 2 years and 1 month An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0\. Severity scale ranges from Grade 1 (Mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse events. 6. Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 Cmax is defined as maximum observed serum concentration of amivantamab. 7. Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 Tmax is defined as time to maximum observed serum concentration of amivantamab. 8. Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC\[t1-t2\]) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of amivantamab. 9. Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC\[0-tau\]) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 AUC(0-tau) is defined as area under the curve from time 0 to tau hours of amivantamab. 10. Cohort 1 and 4: Trough Serum Concentration (Ctrough) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 Ctrough is defined as the serum concentration of amivantamab. 11. Cohort 1 and 4: Accumulation Ratio (R) of Amivantamab Timeframe: Predose up to 168 hours post dose on Day 1 Accumulation ratio (R) is calculated as area under the serum concentration-time curve from time zero to 168 hours (AUC\\\[0-168\\\]) value at Cycle 2 Day 1 dose divided by AUC(0-168) value after Cycle 1 Day 1 amivantamab dose. 12. Cohort 6: Event-Free Survival (EFS) Timeframe: 2 years and 2 months EFS is defined as the time from the first administration of study treatment until the date of radiographic disease progression, local or distant progression or recurrence as assessed with imaging or biopsy as indicated, or death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation - Participant with a history of clinically significant cardiovascular disease - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Sites - University of California at San Diego Moores Cancer CenterLa Jolla, United StatesCompleted - University of Colorado Denver Anschultz Medical CampusAurora, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - The University of Chicago Medical Center (UCMC)Chicago, United StatesRecruiting - University of Maryland School of MedicineBaltimore, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - University of Michigan Rogel Cancer CenterAnn Arbor, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - Washington University School Of MedicineSt Louis, United StatesRecruiting - Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesRecruiting - University of North Carolina at Chapel HillChapel Hill, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - University of Utah Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting - University of VirginiaCharlottesville, United StatesRecruiting - Virginia Cancer SpecialistsFairfax, United StatesRecruiting - Beijing Cancer Hospital of Peking UniversityBeijing, ChinaCompleted - West China School of Medicine/West China Hospital, Sichuan UniversityCheng Du Shi, ChinaRecruiting - Linyi Cancer HospitalLinyi, ChinaCompleted - Fudan Cancer HospitalShanghai, ChinaRecruiting - Shanghai East HospitalShanghai, ChinaRecruiting - Union Hospital Tongji Medical College of Huazhong University of Science and TechnologyWuhan, ChinaRecruiting - Institut Sainte CatherineAvignon, FranceRecruiting - Centre Oscar LambretLille, FranceRecruiting - CHU NantesNantes, FranceRecruiting - Institut CurieParis, FranceRecruiting And 31 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## References - PubMed 42218660 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42218660/) Related publication ### Other registry identifiers (3) - 2023 - 2023-508418-40-00 - 61186372HNC2002 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06385080) ## Related records ### Drugs (4) - [Amivantamab](https://trialight.com/data/asset/amivantamab-94d99890-d90e-4d89-8a02-036a29458456.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Primary condition ### Targets (19) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) - [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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