CompletedPhase 1NCT03735628

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

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.

Checked against the public recordLast updated Oct 6, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations6
SponsorBayer
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Bayer
Interventions being studied
Drug: Copanlisib; Drug: Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Participants with a histologically confirmed diagnosis of: Phase 1b: * Advanced solid tumors where nivolumab is indicated as per the latest nivolumab Prescribing Information, Phase 2: * Metastatic NSCLC, progressing on or after prior pembrolizumab therapy with or without chemotherapy, irrespective of PD-L1 expression Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations. * Recurrent or metastatic HNSCC progressing on or after prior pembrolizumab therapy with or without chemotherapy * HCC progressing after any prior therapy. Exclusion Criteria: * Active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Major surgery, open biopsy or significant traumatic injury ≤ 28 days prior to first administration of study intervention. Central line surgery is not considered major surgery * Symptomatic metastatic brain or meningeal carcinomatosis or tumors unless the participant is \> 6 months from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention. * Other malignancy within the last 5 years except for the following, which are permitted: * curatively treated basal cell/squamous cell skin cancer, * carcinoma in situ of the cervix, * superficial transitional cell bladder carcinoma (if BCG \[Bacillus Calmette-Guerin\] treatment was given, there should be a minimum of 6 months between last dose and enrollment), * in situ ductal carcinoma of the breast after complete resection, * participants with localized, resected and/or low-risk prostate cancer may be eligible after discussion with the sponsor's designated medical representative and sponsor's approval. * Other protocol inclusion/exclusion criteria may apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Tower Hematology/Oncology Medical GroupBeverly Hills, California
  • Orthopaedic Institute for ChildrenLos Angeles, California
  • Rocky Mountain Cancer Centers / Denver, CODenver, Colorado
  • Gabrail Cancer CenterCanton, Ohio
  • Rhode Island HospitalProvidence, Rhode Island
  • Princess Margaret Cancer CentreToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 6, 2023. Always confirm current availability with the study team.

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