NCT06385080Toboroz1/2. fázis
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 287 (tervezett)
- Első benyújtás
- 2024. ápr. 23.
- Kezdés
- 2024. ápr. 22.
- Elsődleges befejezés
- 2032. dec. 27.
- Fő szponzor
- Janssen Research & Development, LLC
- Betegségek
- Fej-nyaki daganatok
- NCT-szám
- NCT06385080
- EU CT-szám
- 2023-508418-40-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 287
- 2024. ápr. 22. és az elsődleges befejezés (2032. dec. 27.) között
- 56 helyszín, 11 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (56)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Beijing Cancer Hospital of Peking University | Beijing | Kína | Befejeződött |
| West China School of Medicine/West China Hospital, Sichuan University | Cheng Du Shi | Kína | Toboroz |
| LinYi Cancer Hospital | Linyi | Kína | Befejeződött |
| Shanghai East Hospital | Shanghai | Kína | Toboroz |
| Fudan Cancer Hospital | Shanghai | Kína | Toboroz |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Kína | Toboroz |
| Universitaetsklinikum Essen (AoR) | Essen | Németország | Toboroz |
| Universitaet Leipzig | Leipzig | Németország | Toboroz |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR | Stuttgart | Németország | Toboroz |
| Hospital Universitari Vall d'Hebron | Barcelona | Spanyolország | Toboroz |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spanyolország | Toboroz |
| Hospital Universitario 12 de Octubre | Madrid | Spanyolország | Toboroz |
| Hospital Universitario Ramón y Cajal | Madrid | Spanyolország | Toboroz |
| Sainte Catherine Institut Du Cancer Avignon-Provence | Avignon Cedex 9 | Franciaország | Toboroz |
| Centre Oscar Lambret | Lille | Franciaország | Toboroz |
| Hospital Hotel Dieu | Nantes | Franciaország | Toboroz |
| Institut Curie | Paris | Franciaország | Toboroz |
| Institut Gustave Roussy | Villejuif | Franciaország | Toboroz |
| Addenbrooke's Hospital | Cambridge | Egyesült Királyság | Toboroz |
| The Royal Surrey County Hospital NHS Foundation Trust | Guildford | Egyesült Királyság | Toboroz |
| University College London Hospitals | London | Egyesült Királyság | Toboroz |
| Royal Marsden Hospital (Sutton) | London | Egyesült Királyság | Toboroz |
| Royal Marsden Hospital | London | Egyesült Királyság | Toboroz |
| Imperial College London and Imperial College Healthcare NHS Trust | London | Egyesült Királyság | Befejeződött |
| The Christie NHS Foundation Trust | Manchester | Egyesült Királyság | Toboroz |
| Aichi Cancer Center | Nagoya | Japán | Toboroz |
| Tokyo Medical University Hospital | Tokyo | Japán | Toboroz |
| Severance Hospital, Yonsei University Health System | Seoul | Dél-Korea | Toboroz |
| Asan Medical Center | Seoul | Dél-Korea | Toboroz |
| Seoul National University Hospital | Seoul | Dél-Korea | Toboroz |
| Samsung Medical Center | Seoul | Dél-Korea | Toboroz |
| University Malaya Medical Centre | Kuala Lumpur | Malajzia | Toboroz |
| Pantai Hospital Kuala Lumpur | Kuala Lumpur | Malajzia | Toboroz |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Lengyelország | Toboroz |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Gliwice | Lengyelország | Toboroz |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Lengyelország | Toboroz |
| Changhua Christian Hospital | Changhua | Tajvan | Toboroz |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Tajvan | Toboroz |
| National Taiwan University Hospital | Taipei | Tajvan | Toboroz |
| Taipei Veterans General Hospital | Taipei | Tajvan | Toboroz |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Tajvan | Toboroz |
| University of Michigan Rogel Cancer Center | Ann Arbor | Egyesült Államok | Toboroz |
| University of Colorado Denver Anschultz Medical Campus | Aurora | Egyesült Államok | Toboroz |
| University of Maryland School of Medicine | Baltimore | Egyesült Államok | Toboroz |
| Dana-Farber Cancer Institute | Boston | Egyesült Államok | Toboroz |
| University of North Carolina at Chapel Hill | Chapel Hill | Egyesült Államok | Toboroz |
| University of Virginia | Charlottesville | Egyesült Államok | Toboroz |
| The University of Chicago Medical Center (UCMC) | Chicago | Egyesült Államok | Toboroz |
| Cleveland Clinic | Cleveland | Egyesült Államok | Toboroz |
| Karmanos Cancer Institute | Detroit | Egyesült Államok | Toboroz |
| Virginia Cancer Specialists | Fairfax | Egyesült Államok | Toboroz |
| University of California at San Diego - Moores Cancer Center | La Jolla | Egyesült Államok | Befejeződött |
| Rutgers Cancer Institute of New Jersey | New Brunswick | Egyesült Államok | Toboroz |
| Yale Cancer Center | New Haven | Egyesült Államok | Toboroz |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Egyesült Államok | Toboroz |
| Washington University School of Medicine | St Louis | Egyesült Államok | Toboroz |
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