Health Condition 1: C439- Malignant melanoma of skin, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Bristol Myers Squibb India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients EMR must meet all the following inclusion criteria to participate in the study 1 Adults (male or female) 18 years or older at index date. 2 Confirmed documented diagnosis of R M SCCHN (as per treating physician discretion), from any of the following primary anatomic sites (including but not limited to) oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, salivary glands, ocular, and parapharyngeal sites. 3 Patients who have received a minimum of 4 cycles of nivolumab monotherapy for R M SCCHN at approved dose of 3 mg per kg every 2 weeks (30 minute intravenous infusion), as per prescribing information (Appendix 1) except in case of disease progression, death, any other reason The 3 mg per kg, 14 day (2 week) period constitutes a cycle. Thus, the overall treatment period for 4 cycles of nivolumab spans around 8 weeks. a Patients who had prior exposure to platinum based chemotherapy for R M SCCHN. b Patients who have up to 6 months of baseline or pre-index period data available in EMR. c Patients who have at least 12 months of follow up data available in EMR from the index date until end of study observation period (31 December 2024) or early discontinuation (patient switching to subsequent therapy, death, lost to follow-up, disease progression or any other reason, whichever occurred first) except in case of death within 12 months from index date.
Exclusion criteria
Exclusion criteria: Patients EMR meeting any of the following criteria will be excluded from the study 1 Patients who received nivolumab 4monotherapy at a dose other than the approved dose of 3 mg per kg every 2 weeks (as per prescribing information, Appendix 1). 2 Patients who received other immunotherapy (immune checkpoint inhibitors such as PD-1 or PD-L1 inhibitors, anti-CTLA-4 agent) before switching to nivolumab monotherapy. 3 Patients who received a combination of nivolumab with any other agent (eg, chemotherapy, targeted therapy, etc.). Patients who enrolled in a clinical trial for cancer treatment since the diagnosis of R M SCCHN. 4 Patients with a diagnosis of cancer other than R M SCCHN within the past 5 years, that required systemic or other relevant treatment. 5 Pregnant or breastfeeding women initiating nivolumab monotherapy for R M SCCHN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the real-world overall survival (rwOS) among patients with recurrent or metastatic Squamous cell carcinoma of head and neck (R/M SCCHN) treated with nivolumab monotherapy up to 4 years post-index follow-up time period.Timepoint: The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]). | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine rwPFS & real-world overall response rate rwORR, including complete response CR partial response PR stable disease SD & disease progression DP as per iRECIST immune Response Evaluation Criteria In Solid Tumors criteria among patients with recurrent metastatic SCCHN on nivolumab monotherapy during the post index follow up time periodTimepoint: The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]). | — |
Countries
India
Contacts
Public ContactDisha S R
Bristol Myers Squibb
Outcome results
None listed