Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Phase 1

• Conditions: eoplasms by site; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002605-38-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

•For Dose escalation: subjects with cervical, ovarian, bladder and CRC,
head and neck, gastric and hepatocellular cancer naive to
immunooncology agents; 1st line melanoma and 1st line/2nd line
NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or
after therapy with anti-PD1/anti-PDL-1 and melanoma subjects
progressed while-on
or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-
4.
•For Dose Expansion: all of the above in escalation except for cervical,
ovarian and CRC
•Progressed, or been intolerant to, at least one standard treatment
regimen, except for subjects in 1st line cohorts.
•ECOG performance status of 0 or 1
•At least 1 lesion with measurable disease at baseline
•Availability of an existing tumor biopsy sample (and consent to allow
pre-treatment tumor biopsy)
Are the trial subjects under 18? yes
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 580

Exclusion Criteria

- Primary CNS tumors or solid tumors with CNS metastases as the only
site of active disease
- Autoimmune disease
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to
informed consent
- Uncontrolled CNS metastases

Study & Design

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