ClinicalTrials.gg
Sign In
CompletedNCT03735628Updated Oct 6, 2023

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

A Phase 1 interventional study of Copanlisib and Nivolumab in Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Hepatocellular Carcinoma (HCC), sponsored by Bayer. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.

Sponsored by Bayer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer (NSCLC)
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Hepatocellular Carcinoma (HCC)
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 16 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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 · Drug: Nivolumab

  • 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 · Drug: Nivolumab

Interventions

  • DrugCopanlisib

    Copanlisib: lyophilisate for reconstitution and further dilution for infusion

  • DrugNivolumab

    Nivolumab: concentrate for solution for infusion

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

6 sites
  • Tower Hematology/Oncology Medical Group
    Beverly Hills, California 90211-1850, United States
  • Orthopaedic Institute for Children
    Los Angeles, California 90001, United States
  • Rocky Mountain Cancer Centers / Denver, CO
    Denver, Colorado 80218, United States
  • Gabrail Cancer Center
    Canton, Ohio 44718, United States
  • Rhode Island Hospital
    Providence, Rhode Island 20903, United States
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 1Z5, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Oct 2022, 47 months.

Of 382 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's 47 months is close to that.

Counting every sponsor, half of 588 studies reached it within 51 months; a quarter within 31 and three quarters within 74.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2018
First posted
Nov 8, 2018
StartActual
Oct 17, 2018
Primary completionActual
Oct 13, 2022
CompletionActual
Oct 13, 2022
Last update
Oct 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03735628
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Nov 8, 2018
Start date
Oct 17, 2018
Primary completion
Oct 13, 2022
Completion
Oct 13, 2022
Last update
Oct 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Copanlisib · Nivolumab

Other studies in this condition

Carcinoma, Non-Small-Cell Lung →

Other studies from this sponsor

Bayer →

Start the discussion