A study to investigate the study drugs Durvalumab and Monalizumab for use inpatients with cancer

Phase 1

Active, not recruiting

• Conditions: Advanced solid tumor; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000662-38-IT
• Lead Sponsor: MEDIMMUNE, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Study Completion: 2021-10-26
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

1. Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
2. Subjects must be at the recurrent/metastatic setting, with selected advanced solid tumors.
3) Subjects must have at least one lesion that is measurable by RECIST v1.1
4) Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than two lines of systemic therapy in the recurrent/metastatic setting.

Please refer to the protocol for a full list of the inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 596
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.

2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed

3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment

4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable

Please refer to the protocol for a full list of the exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified