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Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC

NCT03624231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-31

No results posted yet for this study

Summary

Phase II trial evaluating to assess the feasibility and efficacy as first-line therapy for patients with non-resectable locally advanced HPV negative HNSCC of Durvalumab a PDL1-Inhibitor plus Tremelimumab a CTLA-4- Inhibitor in combination with radiotherapy and Durvalumab in combination with radiotherapy as first-line therapy.

2-arm, randomized, multicenter, phase II. Step 1 is Registration. All patients need to sign the informed consent form for registration. Tumor tissue then be send to the central lab for defining the HPV status. If the patient is HPV negative the site will be notified if they can further proceed to patient randomization.

Step 2 is Randomization of all eligible patients with a centrally diagnosed, HPV negative tumor in one of the two arms (Durvalumab plus Tremelimumab + radiotherapy; Durvalumab + radiotherapy) after signing the informed consent form for step 2.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Durvalumab

Durvalumab (1500 mg) starting on week 1 to complete a total of 12 months

DRUG

Tremelimumab

Tremelimumab (75 mg) for up to 4 doses/cycles

RADIATION

Radiotherapy

Radiotherapy with 35 fractions (administered as daily fractions of 2 Gy given 5 days every week for 7 weeks)

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Ulrich Keilholz

    lead OTHER

Principal Investigators

  • Ulrich Keilholz, MD · Charité Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2023-08-17
Completion
2023-08-17

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624231 on ClinicalTrials.gov