A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
John Sfakianos
Study ID
NCT06503614
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Key Dates

Start date
Feb 24, 2025
Status verified
Apr 2026
Primary completion
Dec 22, 2027
Completion
Dec 22, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Durvalumab and Monalizumab for CIS +/- high grade papillary urothelial cancer
    Durvalumab 1500mg IV and monalizumab 1500mg IV will be administered to all patients once every 4 weeks. A cycle is equal to 4 weeks. This will continue until disease progression, unacceptable toxicity, or for a maximum of 1 year.
  • Experimental: Cohort B: Durvalumab and Monalizumab for high grade papillary urothelial cancer without CIS
    Durvalumab 1500mg IV and monalizumab 1500mg IV will be administered to all patients once every 4 weeks. A cycle is equal to 4 weeks. This will continue until disease progression, unacceptable toxicity, or for a maximum of 1 year.

Primary Outcome Measure

Complete Response [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Arfa Mustasam, MBBS, CCRP
[email protected]
813-745-7272
Juskaran Chadha, DO (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Alicia Alexander-Moore
[email protected]
732-235-9850
Saum Ghodoussipour, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Lindsay Diamond
[email protected]
John P Sfakianos, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CenterNew YorkNew York10065
Amalia Korniyenko
[email protected]
646-962-9406
Douglas Scherr, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FLRutgers Cancer Institute of New Jersey· New Brunswick, NJIcahn School of Medicine at Mount Sinai· New York, NYWeill Cornell Medical Center· New York, NY

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