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

A Phase II Study of Adjuvant Nivolumab Switch from Intravenous (IV) to Subcutaneous (SC) Use in Participants with Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000294-67-DE

Enrollment

Registered

2022-07-20

Start date

2022-12-21

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III A/B/C/D, Stage IV melanoma or Muscle-Invasive Urothelial Carcinoma

Interventions

Product Name: Nivolumab Subcutaneous coformulated with excipient rHuPH20 Product Code: BMS-986298-01 Pharmaceutical Form: Solution for injection INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

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Secondary

Measure	Time frame
Secondary end point(s): -Incidence of all AEs, SAEs, treatment-related AEs including IMAEs, AEs & SAEs leading to discontinuation or death -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 - After the second assessment of the patient experience and preference questionnaire	—

Measure

Time frame

Secondary end point(s): -Incidence of all AEs, SAEs, treatment-related AEs including IMAEs, AEs & SAEs leading to discontinuation or death -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 - After the second assessment of the patient experience and preference questionnaire

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Countries

Germany, Italy, Spain, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com0034914565300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026