ABIMMUNE: A Phase I/II study evaluating the safety and clinical activity of anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) antibodies administrated in combination with stereotactic body radiotherapy (SBRT) in patients with metastatic squamous cell carcinoma of head and neck, lung, oesophageus, cervix, vagina, vulva or anus.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514920-18-00

Acronym

CSET N°2016/2454

Enrollment

Registered

2024-07-09

Start date

2017-06-20

Completion date

2025-02-24

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervix, esophagus, lung, Metastatic squamous cell carcinoma of head and neck, vagina, vulva or anus to be treated with SBRT

Brief summary

Phase I: dose limiting toxicities (AE assessed using CTCAE v 4.03), Phase II: CT-SCAN evaluation outside the field of focal radiotherapy

Detailed description

RECIST 1.1 and irRC, Adverse events based on CTCAE-V4

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: dose limiting toxicities (AE assessed using CTCAE v 4.03), Phase II: CT-SCAN evaluation outside the field of focal radiotherapy	—

Secondary

Measure	Time frame
RECIST 1.1 and irRC, Adverse events based on CTCAE-V4	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026