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Tables of reported side effects from clinical trials detailing frequency and severity of reactions to Nivolumab and Relatlimab in cancer patients.
Year: 2025
Region / Country: United States
Subject: Oncology / Immunotherapy
Document Type: Patient Educational Material
Organization: National Cancer Institute (NCI)
Intended Audience: Research staff, clinical trial participants
Version Date: December 5, 2025
Drug Names: Nivolumab, Relatlimab (Opdualag)
Side Effect Categories: Common, Occasional, Rare
Clinical Trial Networks: CTEP-supported US sites
Regulatory Note: Not approved by NCI CIRB as patient information sheet for trials
Price: 8 / 10 USD
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Supplementary Methods Relatlimab epitope characterization
Year: 2023
Region / City: Uppsala, Sweden; Birmingham, AL, USA; Chicago, IL, USA; Minneapolis, MN, USA; San Diego, CA, USA
Topic: Binding affinity and epitope specificity of relatlimab
Document Type: Scientific Methodology
Organization: Biacore, Southern Biotech, R&D Systems, Cytiva, Biomol/Enzo Life Sciences, Bristol Myers Squibb
Author: Unspecified
Target Audience: Researchers in biochemistry, immunology, and pharmaceutical development
Period of Validity: N/A
Approval Date: N/A
Date of Changes: N/A
NIVOLUMAB, Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. Infusion 100 mg in 10 mL, Opdivo®, BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD
Year: 2023
Region / City: Australia
Topic: Oncology, Urothelial carcinoma, Immunotherapy
Document type: Medical submission
Organization / Institution: Bristol-Myers Squibb Australia Pty Ltd
Author: Unknown
Target audience: Medical practitioners, healthcare professionals
Period of validity: Ongoing
Approval date: 2023
Date of amendments: N/A
Source: TGA/PBAC Parallel Process
Indication: First-line treatment for unresectable or metastatic urothelial carcinoma
Treatment phase: Initial and Continuing treatment
Condition: Unresectable or metastatic urothelial carcinoma
Treatment criteria: Patient must meet specific clinical and therapeutic criteria
NIVOLUMAB, Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL Opdivo®IPILIMUMAB Injection concentrate for I.V. infusion 50 mg in 10 mL Yervoy®
Year: 2024
Region / City: Australia
Subject: Nivolumab and ipilimumab treatment for unresectable malignant mesothelioma
Document type: Submission report
Organ / Institution: PBAC, DUSC, TGA
Author: Unknown
Target audience: Pharmaceutical regulators, healthcare professionals
Period of validity: 2021-2024
Approval date: July 2021
Date of changes: March 2024
NIVOLUMAB plus IPILIMUMAB, NIVOLUMAB: Injection concentrate for I.V. infusion 100 mg in 10 mL, Injection concentrate for I.V. infusion 40 mg in 4 mL, OPDIVO®; IPILIMUMAB: Injection concentrate for I.V. infusion 200 mg in 40 mL, Injection concentrate for I.V. infusion 50 mg in 10 mL, YERVOY®; Bristol-Myers Squibb Australia Pty Ltd
Year: 2022
Region / City: Australia
Theme: Oncology, Medical Treatment
Document Type: Pharmaceutical Submission
Organization / Institution: Bristol-Myers Squibb Australia Pty Ltd
Author: Not specified
Target Audience: Medical professionals, Oncologists
Period of validity: Ongoing
Approval Date: 4 July 2018
Date of Changes: Not specified
Note: Contextual Description
NIVOLUMAB, Injection concentrate for I.V. infusion 40 mg in 4 mL, 100 mg in 10 mL, Opdivo®, Bristol-Myers Squibb Australia Pty Ltd
Year: 2021
Region / city: Australia
Theme: Cancer treatment
Document type: Submission for Authority Required listing
Organization / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Bristol-Myers Squibb Australia Pty Ltd
Target audience: Medical practitioners
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
7.07 NIVOLUMAB, Injection concentrate for I.V. infusion, 40 mg in 4 mL, 100 mg in 10 mL, Opdivo®, as monotherapy, or in combination with IPILIMUMAB, Injection concentrate for I.V. infusion, 50 mg in 10 mL, 200 mg in 40 mL, Yervoy®, Bristol-Myers Squibb
Year: 2023
Region / City: Australia
Subject: Cancer Treatment / Immunotherapy
Document Type: Submission
Organ / Institution: Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Bristol-Myers Squibb
Target Audience: Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity: Ongoing
Approval Date: Not specified
Date of Changes: Not specified
NIVOLUMAB Injection concentrate for I.V. infusion 40 mg in 4 mL, 100 mg in 10 mL - Opdivo® resubmission for adjuvant melanoma treatment
Year: 2019
Region / city: Australia
Theme: Oncology, Chemotherapy
Document type: Resubmission for PBS listing
Organ / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Bristol-Myers Squibb Australia Pty Ltd
Target audience: Medical professionals, PBAC members
Validity period: Not specified
Approval date: Not specified
Amendment date: Not specified
Nivolumab for the adjuvant treatment of melanoma
Year: 2019
Region / city: Australia
Topic: Adjuvant melanoma treatment
Document type: Public Summary Document
Organization / institution: PBAC
Author: PBAC
Target audience: Healthcare professionals
Period of validity: Not specified
Approval date: July 2019
Date of changes: July 2019
Supplementary Figures on T Cell Dynamics During Chemoradiotherapy and Nivolumab Treatment
Year: 2026
Study type: Immunology / Oncology
Document type: Supplementary material
Institution: Research laboratory or medical center
Methods: Flow cytometry, 16S rRNA sequencing
Subjects: Tumor-infiltrating lymphocytes and peripheral blood mononuclear cells
Treatment: Chemoradiotherapy followed by nivolumab
Markers analyzed: CD8+, CD4+, Ki-67, CTLA-4
Sample type: Tumor tissue and stool
Period of study: Pre- and post-chemoradiotherapy
Audience: Scientific community
Topics: Opdualag Relatlimab NIVOLUMAB