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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-17

Study Completion Date

2022-10-13

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Copanlisib

Intervention Type DRUG

Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Nivolumab

Intervention Type DRUG

Nivolumab: concentrate for solution for infusion

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).

Group Type EXPERIMENTAL

Copanlisib

Intervention Type DRUG

Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Nivolumab

Intervention Type DRUG

Nivolumab: concentrate for solution for infusion

Interventions

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Copanlisib

Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Intervention Type DRUG

Nivolumab

Nivolumab: concentrate for solution for infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No