An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Bayer
Study ID
NCT03735628
Phase
PHASE1
Status
Completed

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Hepatocellular Carcinoma (HCC)
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Copanlisib — DRUG
    Copanlisib: lyophilisate for reconstitution and further dilution for infusion
  • Nivolumab — DRUG
    Nivolumab: concentrate for solution for infusion

Study Details

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Key Dates

Start date
Oct 17, 2018
Status verified
Oct 2023
Primary completion
Oct 13, 2022
Completion
Oct 13, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Copanlisib: 45 mg (dose level -1) or 60 mg (dose level 1) on Day 1, Day 8 and Day 15 (28 day cycle) Nivolumab: 240 mg on Day 15 of Cycle 1 and on Day 1 and Day 15 of subsequent cycles (28 day cycle).
  • Experimental: Dose expansion
    Copanlisib: Recommended phase 2 dose established in the phase 1b part on Day 1, Day 8 and Day 15 (28 day cycle) Nivolumab: 240 mg on Day 15 of Cycle 1 and on Day 1 and Day 15 of subsequent cycles (28 day cycle).

Primary Outcome Measure

Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumab [ Time Frame: At the end of Cycle 2 of a 28-day cycle ]

Locations (5)

FacilityCityStateZIPSite coordinators
Tower Hematology/Oncology Medical GroupBeverly HillsCalifornia90211-1850-
Orthopaedic Institute for ChildrenLos AngelesCalifornia90001-
Rocky Mountain Cancer Centers / Denver, CODenverColorado80218-
Gabrail Cancer CenterCantonOhio44718-
Rhode Island HospitalProvidenceRhode Island20903-

Find similar trials in Beverly Hills, CA

By research site
Tower Hematology/Oncology Medical Group· Beverly Hills, CAOrthopaedic Institute for Children· Los Angeles, CARocky Mountain Cancer Centers / Denver, CO· Denver, COGabrail Cancer Center· Canton, OHRhode Island Hospital· Providence, RI

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