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

Conditions:Lung Cancer, Colorectal Cancer, Liver Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 16, 2018
End Date:April 30, 2021
Contact:Bayer Clinical Trials Contact
Phone:(+)1-888-84 22937

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An Open-label, Multi-center, Phase 1b/2 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.

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, relapsed after prior platinum containing chemotherapy, irrespective
of PD-L1 expression AND non-responding (no CR/PR) nonprogressing (no PD) on current
nivolumab treatment. Patients with Epidermal growth factor receptor (EGFR) or
Anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations. Participants must have been
on nivolumab therapy for at least 3 months prior to screening.

- Recurrent or metastatic HNSCC with disease progression on or after platinum-containing

- Microsatellite instability-high (MSI-H)/ Mismatch repair deficient) dMMR metastatic
CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and

- HCC previously treated with Sorafenib

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

- 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

- 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.
We found this trial at
593 Eddy Street
Providence, Rhode Island 02903
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
Providence, RI
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4875 Higbee Ave NW
Canton, Ohio 44718
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
Canton, OH
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Santa Monica, California 90403
Santa Monica, CA
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