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NCT06959108: IDEAL
Randomized Phase 2 Trial of Induction Treatment of Anti-PD-1 Pucotenlimab and EGFR-ADC MRG003 Versus EGFR-ADC Alone Followed by Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN).
Phase 2 trial testing Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma in 106 participants. Currently enrolling.
1 June 2029
Quick facts
| Lead sponsor | Groupe Oncologie Radiotherapie Tete et Cou |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 13 October 2025 |
| Primary completion | 1 June 2029 |
| Estimated completion | 1 October 2029 |
| Sites | 1 location across France |
Drugs / interventions tested
- Pucotenlimab — full drug profile →
- MRG003 — full drug profile →
Conditions studied
- Locally Advanced Head and Neck Squamous Cell Carcinoma — all drugs for Locally Advanced Head and Neck Squamous Cell Carcinoma →
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou — full company profile →
Who can join
Adults 18 to 75, any sex, with Locally Advanced Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
objective response rate
Time frame: around 20 months after the inclusion of the 1st patient
objective response rate evaluated by the investigators with head and neck radiological imaging according to RECIST version 1.1 criteria at the end of induction phase of EGFR-ADC MRG003 + anti-PD-1 Pucotenlimab or EGFR-ADC MRG003 alone
Sponsor's own description
The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy. People eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy). Half of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant\* after radiochemotherapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06959108
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pucotenlimab
Trials testing the same drug.
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- NCT07448142 — Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT07353827 — FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarc · Phase 2 · not yet recruiting
- NCT07394244 — Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma · Phase 2 · not yet recruiting
Other recruiting trials for Locally Advanced Head and Neck Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07524452 — Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, · Phase 3 · recruiting
- NCT07369882 — Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Adva · NA · recruiting
- NCT07371234 — Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck · Phase 2 · recruiting
- NCT06470217 — Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT06240689 — A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy f · Phase 2 · recruiting
Other Groupe Oncologie Radiotherapie Tete et Cou trials
Trials by the same sponsor.
- NCT06640725 — Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell · Phase 2 · recruiting
- NCT05930938 — Study Comparing RT With Cetuximab + Xevinapant to RT With Cetuximab-placebo in Patients With Head and Neck Cancer · Phase 3 · terminated
- NCT05930951 — Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck · Phase 1 · terminated
- NCT04356170 — Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma · Phase 2 · completed
- NCT03330249 — Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06959108 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06959108.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing