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

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ClinicalTrials.gov Identifier: NCT03735628
Recruitment Status : Active, not recruiting
First Posted : November 8, 2018
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) Hepatocellular Carcinoma (HCC) Drug: Copanlisib Drug: Nivolumab Phase 1 Phase 2

Detailed Description:
Study was originally designed with both Phase I and Phase II part, but sponsor decided not to conduct Phase 2 part due to strategic portfolio re-prioritization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : September 17, 2021
Estimated Study Completion Date : September 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation

Copanlisib:

45 mg (dose level -1) or 60 mg (dose level 1) on Day 1, Day 8 and Day 15 (28 day cycle)

Nivolumab:

240 mg on Day 15 of Cycle 1 and on Day 1 and Day 15 of subsequent cycles (28 day cycle).

Drug: Copanlisib
Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Drug: Nivolumab
Nivolumab: concentrate for solution for infusion

Experimental: Dose expansion

Copanlisib:

Recommended phase 2 dose established in the phase 1b part on Day 1, Day 8 and Day 15 (28 day cycle)

Nivolumab:

240 mg on Day 15 of Cycle 1 and on Day 1 and Day 15 of subsequent cycles (28 day cycle).

Drug: Copanlisib
Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Drug: Nivolumab
Nivolumab: concentrate for solution for infusion




Primary Outcome Measures :
  1. Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumab [ Time Frame: At the end of Cycle 2 of a 28-day cycle ]
  2. Phase 2: Overall response rate (ORR) as per RECIST v 1.1 (Response evaluation criteria in solid tumors, v 1.1) (by local investigator [ Time Frame: Up to 26 months ]

Secondary Outcome Measures :
  1. Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment) [ Time Frame: Up to 26 months ]
  2. Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib [ Time Frame: At cycle1 day15, cycle2 day15, cycle 6 day15 ]
  3. Phase 1b and 2:Area under the curve (AUC) of copanlisib [ Time Frame: At cycle1 day15, cycle2 day15,cycle 6 day15 ]
  4. Phase 1b and 2: Cmax for nivolumab [ Time Frame: At cycle1 day15, cycle2 day15,cycle 6 day15 ]
  5. Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab [ Time Frame: At cycle1 day15, cycle2 day15,cycle 6 day15 ]
  6. Phase 1b and 2: Overall survival (OS) [ Time Frame: Up to 26 months ]
  7. Phase 1b and 2: Progression-free survival (PFS) [ Time Frame: Up to 26 months ]
  8. Phase 1b and 2: Disease control rate (DCR) [ Time Frame: Up to 26 months ]
  9. Phase 1b and 2: Duration of stable disease (DSD) [ Time Frame: Up to 26 months ]
  10. Phase 1b and 2: Time to response (TTR) [ Time Frame: Up to 26 months ]
  11. Phase 1b and 2: Time to progression (TTP) [ Time Frame: Up to 26 months ]
  12. Phase 1b and 2: Duration of response (DOR) [ Time Frame: Up to 26 months ]
  13. Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE) [ Time Frame: Up to 26 months ]
  14. Phase 1b and 2:Number of participants with clinically significantly abnormal changes in electrocardiograms (ECG) including heart rate and measures PR, QRS, QT, and QTc intervals [ Time Frame: Up to 26 months ]
  15. Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity [ Time Frame: Up to 26 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735628


Locations
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United States, California
Tower Hematology/Oncology Medical Group
Beverly Hills, California, United States, 90211-1850
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903-4900
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03735628    
Other Study ID Numbers: 19769
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Carcinoma
Carcinoma, Hepatocellular
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Head and Neck Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents