FOI release

FOI Request [BRIS-WORKSITE.FID4549677]

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/00185

Received 26 February 2025

Published 30 May 2025

Request

Dear Medicines & Healthcare products Regulatory Agency Pursuant to the Freedom of Information Act 2000, in relation to the clinical trial titled "A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors", which has the EudraCT number 2014-002605-38, please provide copies of: 1. A copy of Revised Protocol 7 (dated 20 December 2016). 2. A copy of Revised Protocol 8 (dated 31 July 2017). 3. A copy of the Investigator's Brochure. 4. A copy of the patient informed consent forms. 5. Copies of any minutes or decisions relating to the approval of the trial and/or amendments to the trial protocol. The MHRA approved the protocol on 21 November 2016. The sponsor was Bristol-Myers Squibb International Corporation. Please let us know if you require any further information from us.

Response

see attached

Documents

• bms936558-ib23-redacted.pdf (18.1 MB)
• ca224020-revprot07-redacted.pdf (10.2 MB)
• ca224020-revprot08-redacted.pdf (12.2 MB)
• FOI2025_00185 redacted for publication.pdf (127.1 KB)

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