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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 6, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Bayer
- Interventions being studied
- Drug: Copanlisib; Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.