Non-small Cell Lung Cancer (NSCLC)Phase 1NCT03735628
An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors
A Phase 1 study testing Copanlisib and Nivolumab in people with Non-small Cell Lung Cancer (NSCLC) and Head and Neck Squamous Cell Carcinoma (HNSCC), run by Bayer at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatocellular Carcinoma (HCC)
- What is being tested?
- Copanlisib and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Oct 2018to 13 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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 locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Tower Hematology/Oncology Medical Group
Beverly Hills, California, 90211-1850
Gabrail Cancer Center
Canton, Ohio, 44718
Rocky Mountain Cancer Centers / Denver, CO
Denver, Colorado, 80218
Orthopaedic Institute for Children
Los Angeles, California, 90001
Rhode Island Hospital
Providence, Rhode Island, 20903
About this study
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.
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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatocellular Carcinoma (HCC)
- Being tested
- Copanlisib, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopanlisibDrug
Copanlisib: lyophilisate for reconstitution and further dilution for infusion
NivolumabDrug
Nivolumab: concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | 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). Receives: Drug: Copanlisib; Drug: Nivolumab |
| Dose expansion | Experimental | 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). Receives: Drug: Copanlisib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumab
Measured: 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
Measured: Up to 26 months
Secondary outcomes (15)
Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)
Measured: Up to 26 months
Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib
Measured: At cycle1 day15, cycle2 day15, cycle 6 day15
Phase 1b and 2:Area under the curve (AUC) of copanlisib
Measured: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Cmax for nivolumab
Measured: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab
Measured: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Overall survival (OS)
Measured: Up to 26 months
Phase 1b and 2: Progression-free survival (PFS)
Measured: Up to 26 months
Phase 1b and 2: Disease control rate (DCR)
Measured: Up to 26 months
Phase 1b and 2: Duration of stable disease (DSD)
Measured: Up to 26 months
Phase 1b and 2: Time to response (TTR)
Measured: Up to 26 months
Phase 1b and 2: Time to progression (TTP)
Measured: Up to 26 months
Phase 1b and 2: Duration of response (DOR)
Measured: Up to 26 months
Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)
Measured: 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
Measured: Up to 26 months
Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start17 Oct 2018
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735628
- Sponsor's protocol ID
- 19769
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03735628
- Acronym / sponsor ID
- 19769
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: Copanlisib, Drug: NivolumabCopanlisib: 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). |
| Dose expansion | Experimental | Drug: Copanlisib, Drug: NivolumabCopanlisib: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with a histologically confirmed diagnosis of:
- Advanced solid tumors where nivolumab is indicated as per the latest nivolumab Prescribing Information,
- 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.
Key exclusion criteria (10 listed)
- 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:
- Other protocol inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CopanlisibCopanlisib: lyophilisate for reconstitution and further dilution for infusion | Drug | Dose escalation, Dose expansion |
| NivolumabNivolumab: concentrate for solution for infusion | Drug | Dose escalation, Dose expansion |
Primary outcome
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
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
15 secondary outcomes
Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)
Time frame: Up to 26 months
Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib
Time frame: At cycle1 day15, cycle2 day15, cycle 6 day15
Phase 1b and 2:Area under the curve (AUC) of copanlisib
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Cmax for nivolumab
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Overall survival (OS)
Time frame: Up to 26 months
Phase 1b and 2: Progression-free survival (PFS)
Time frame: Up to 26 months
Phase 1b and 2: Disease control rate (DCR)
Time frame: Up to 26 months
Phase 1b and 2: Duration of stable disease (DSD)
Time frame: Up to 26 months
Phase 1b and 2: Time to response (TTR)
Time frame: Up to 26 months
Phase 1b and 2: Time to progression (TTP)
Time frame: Up to 26 months
Phase 1b and 2: Duration of response (DOR)
Time frame: Up to 26 months
Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)
Time 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
Time frame: Up to 26 months
Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity
Time frame: Up to 26 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Copanlisib and Nivolumab in people with Non-small Cell Lung Cancer (NSCLC) and Head and Neck Squamous Cell Carcinoma (HNSCC), run by Bayer at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.