Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07276399 | A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer | PHASE3 | RECRUITING | 500 | — | — | Dec 3, 2025 | Jun 18, 2029 | Jun 5, 2026 | 186 | United States, Australia +20 |
| NCT06385080 | A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer | PHASE1 | RECRUITING | 287 | — | — | Apr 22, 2024 | Dec 27, 2032 | Jun 5, 2026 | 56 | United States, China +9 |
OS is defined as time from the date of randomization to the date of death due to any cause.
ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 .
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.
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.
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.
The participants who achieve MPR at the time of surgery.
| Arm | Type | Description |
|---|---|---|
| Arm A: Pembrolizumab, Amivantamab, Carboplatin | EXPERIMENTAL | Participants will receive pembrolizumab, amivantamab and carboplatin. |
| Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin | ACTIVE_COMPARATOR | Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy). |
| Cohort 1: Amivantamab Monotherapy (Dose Expansion) | EXPERIMENTAL | 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. |
| Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in) | EXPERIMENTAL | 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). |
| Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel | EXPERIMENTAL | 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. |
| Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel | EXPERIMENTAL | 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. |
| Cohort 4: Amivantamab Monotherapy | EXPERIMENTAL | 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. |
| Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion) | EXPERIMENTAL | 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. |
| Cohort 6: Amivantamab + Pembrolizumab | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Amivantamab | BIOLOGICAL | Amivantamab will be administered. |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab will be administered. |
| Carboplatin | DRUG | Carboplatin will be administered. |
| 5-Flurouracil | DRUG | 5-Flurouracil will be administered for over 4-day infusion period. |
| Cisplatin | DRUG | Cisplatin will be administered. |
| Paclitaxel | DRUG | Paclitaxel will be administered intravenously. |
Inclusion criteria: * Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) * Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local th...