Trial Condition(s):

Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Hepatocellular carcinoma (HCC)

An study to evaluate the safety and efficacy of copanlisib in combination with nivolumab in patients with advanced solid tumors

Bayer Identifier:

19769 Identifier:


EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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, 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

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers

Where to Participate


Rhode Island Hospital

Providence, United States, 20903


Orthopaedic Institute for Children

Los Angeles, United States, 90001


Gabrail Cancer Center

Canton, United States, 44718


Princess Margaret Cancer Centre

Toronto, Canada, M5G 1Z5


Rocky Mountain Cancer Centers / Denver, CO

Denver, United States, 80218


Tower Hematology/Oncology Medical Group

Beverly Hills, United States, 90211-1850

Trial Design