A Study of Nivolumab IV to Subcutaneous Switch in Adjuvant Melanoma and Bladder Cancer

Phase 1

• Conditions: Stage III A/B/C/D, Stage IV melanoma or Muscle-Invasive Urothelial Carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-000294-67-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

- Eligible for adjuvant therapy for melanoma or muscle-invasive urothelial carcinoma originating from the bladder
• Melanoma: resected Stage IIIA/B/C/D or Stage IV (AJCC 8th edition)
• Bladder: pT3-pT4a or pN+ ineligible or refusal of adjuvant cisplatin chemotherapy OR ypT2-pT4a or ypN+ who received neo-adjuvant cisplatin chemotherapy
- ECOG performance status 0-1; =18

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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

• Ocular or mucosal melanoma
• Upper tract urothelial carcinoma (ureter, renal pelvis), NMIBC
• Untreated/unresected CNS or leptomeningeal metastases
• Prior treatment with immuno-oncology agents

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate participants' preference upon switching from Nivo IV to Nivo SC ;Secondary Objective: To assess the safety and tolerability of Nivo SC and Nivo IV<br>To evaluate participants' preference for Nivo SC after the switch period ;Primary end point(s): Proportion of participants that prefer Nivo SC at the first assessment of patient preference using PEPQ (Question 1);Timepoint(s) of evaluation of this end point: After the first assessment of patient experience and preference questionnaire

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Incidence of all AEs, SAEs, treatment-related AEs including IMAEs, AEs & SAEs leading to discontinuation or death<br>-Proportion of participants that prefer Nivo SC at the second patient preference assessment using PEPQ (Question 1);Timepoint(s) of evaluation of this end point: - Throughout the treatment period, lasting from start of Nivo IV until 100 days following discontinuation of Nivo dosing<br>- After the second assessment of the patient experience and preference questionnaire