check_circleStudy Completed

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

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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/exclusion criteria may apply

Trial summary

Enrollment Goal
16
Trial Dates
October 2018 - October 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Rhode Island HospitalProvidence, 20903, United States
Completed
Orthopaedic Institute for ChildrenLos Angeles, 90001, United States
Completed
Gabrail Cancer CenterCanton, 44718, United States
Completed
Princess Margaret Cancer CentreToronto, M5G 1Z5, Canada
Completed
Rocky Mountain Cancer Centers / Denver, CODenver, 80218, United States
Completed
Tower Hematology/Oncology Medical GroupBeverly Hills, 90211-1850, United States
Withdrawn
Charleston Hematology & Oncology Associates, PACharleston, 29414, United States
Withdrawn
University of Toledo Medical CenterToledo, 43614, United States
Withdrawn
Texas Oncology-Fort WorthFort Worth, 76104, United States
Withdrawn
Willamette Valley Cancer Institute and Research CenterEugene, 97401, United States
Withdrawn
Beverly Hills Cancer CenterBeverly Hills, 92663, United States

Primary Outcome

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

Secondary Outcome

  • Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib
    date_rangeTime Frame:
    At cycle1 day15, cycle2 day15, cycle 6 day15
  • Phase 1b and 2:Area under the curve (AUC) of copanlisib
    date_rangeTime Frame:
    At cycle1 day15, cycle2 day15,cycle 6 day15
  • Phase 1b and 2: Cmax for nivolumab
    date_rangeTime Frame:
    At cycle1 day15, cycle2 day15,cycle 6 day15
  • Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab
    date_rangeTime Frame:
    At cycle1 day15, cycle2 day15,cycle 6 day15
  • Phase 1b and 2: Overall survival (OS)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Progression-free survival (PFS)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Disease control rate (DCR)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Duration of stable disease (DSD)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Time to response (TTR)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Time to progression (TTP)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2: Duration of response (DOR)
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)
    date_rangeTime Frame:
    Up to 26 months
  • 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
    date_rangeTime Frame:
    Up to 26 months
  • Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity
    date_rangeTime Frame:
    Up to 26 months

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2