Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Nivolumab

Capecitabine

Immunomodulating Agents

Ipilimumab

Mitomycins

Mitomycin

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Nivolumab monotherapy at 480mg fixed dose administered intravenously (IV) over 60 minutes every 4 weeks for 3 doses.

All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.

Nivolumab at 3 mg/kg administered IV over 60 minutes combined with ipilimumab at 1 mg/kg administered IV over 90 minutes every 3 weeks for 4 doses.

All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.

Nivolumab at 1 mg/kg administered IV over 60 minutes combined with ipilimumab at 3 mg/kg administered IV over 90 minutes every 3 weeks for 4 doses.

All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.

nivolumab 480mg

nivolumab 3mg/kg, ipilimumab 1mg/kg

nivolumab 1mg/kg, ipilimumab 3mg/kg

Adriaan D. Bins, MD PhD

Tom van der Hulle, MD, PhD

A multicenter Phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy in adult (\>18 years) subjects with non-metastatic muscle invasive bladder cancer that qualify for ChRT with curative intent.

Immunotherapy combined with chemoradiation for localized bladder cancer may exhibit improved efficacy with an acceptable toxicity profile.

The aim of this phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy stuy is: to assess the feasibility and safety, the disease free survival (DFS) and disease free survival rate (DFS-rate) of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.

Patients will be treated with radiation therapy over 4 weeks and receive MMC IV on day1 of radiation therapy and capecitabine on each day of radiation therapy as radiosensitizers.

Phase-1b: enrollment of maximum of 30 patients with a maximum of 10 patients per treatment regimen, in order to determine optimal regimen based on the occurrence of dose limiting toxicities (DLT).

* Regimen-A: immunotherapy (w1-12) consists of nivolumab 480mg (fixed dose), on day(d)1, d29 and d57.
* Regimen-B: immunotherapy (w1-12) consists of ipilimumab 1 mg/kg together with Nivolumab 3mg/kg on d1, d22, d43 and d65.
* Regimen-C: immunotherapy (w1-12) consists of ipilimumab 3 mg/kg and nivolumab 1 mg/kg on d1, d22, d43 and d65.

All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.

Phase-2: enrollment of an additional 20 subjects at the regimen determined to be optimal in the phase-1b part.

A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study

A Phase 1b-2 Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study

Cystoscopy at week 12 and week 24 will be performed. From week 12 onward 3-montly CT scans will be done in the context of the current standard of care up to 5 years.

Bristol-Myers Squibb

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Principal Investigator

Spots Global Cancer Trial Database for nivolumab 480mg