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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    160
  • sponsor
    Bayer
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Updated on 25 December 2020
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Investigator
Bayer Clinical Trials Contact
Primary Contact
Rhode Island Hospital (9.6 mi away) Contact
+11 other location
growth factor
oxaliplatin
fluoropyrimidine
epidermal growth factor receptor
EGFR
nivolumab
cancer chemotherapy
epidermal growth factor

Summary

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.

Details
Treatment Nivolumab, Copanlisib
Clinical Study IdentifierNCT03735628
SponsorBayer
Last Modified on25 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: HEPATOCELLULAR CARCINOMA or Rectal Disorders or HEPATIC NEOPLASM or Colorectal Cancer or Liver Cancer or Malignant Adenoma or Rectal disorder or Non-S...?
Do you have any of these conditions: HEPATIC NEOPLASM or Rectal Disorders or Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Cancer (CRC), He...?
Do you have any of these conditions: Adenocarcinoma or colorectal tumor or Squamous Cell Carcinoma of Head and Neck or Rectal disorder or HEPATIC NEOPLASM or nsclc or Colon cancer; rectal...?
Do you have any of these conditions: cancer, colorectal or colorectal tumor or nsclc or Squamous Cell Carcinoma of Head and Neck or Squamous Cell Carcinoma of the Head and Neck or Liver C...?
Do you have any of these conditions: nsclc or liver cell carcinoma or Squamous Cell Carcinoma of Head and Neck or colorectal neoplasm or cancer, colorectal or tumors, colorectal or HEPATO...?
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 chemotherapy
Microsatellite instability-high (MSI-H)/ Mismatch repair deficient) dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
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 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
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