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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04850755
Other study ID # CA209-7EL (BMS); IST-313 (KPT)
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 8, 2021
Est. completion date November 2024

Study information

Verified date November 2020
Source National University Hospital, Singapore
Contact David Shao Peng Tan
Phone 6772 4661
Email David_SP_Tan@nuhs.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-centre, phase 1a (dose escalation) and 1b (dose expansion) study to evaluate the safety and tolerability of oral Selinexor in combination with nivolumab and ipilimumab in patients with advanced solid malignancies.


Description:

Primary Objectives - To evaluate the safety and tolerability of selinexor in combination with nivolumab and ipilimumab - To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of selinexor in combination with nivolumab and ipilimumab in patients with advanced or metastatic solid tumor malignancies. Secondary Objectives - To determine Selinexor pharmacokinetics (PK) in Asian patients - To describe anti-tumor responses with the combination in patients with advanced or metastatic solid tumor malignancies. Exploratory Objectives - To assess the immunomodulatory effects of selinexor in solid tumour malignancies and circulating immune cells - To identify biomarkers of response to the combination of selinexor and nivolumab + ipilimumab. We will explore changes in PDL1 expression, T cell infiltration (including CD4 and CD8 positive cells), gene expression profiles on serial tumor biopsies pre-selinexor, post-selinexor alone, and after the combination of selinexor and ipilimumab + nivolumab where feasible.


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Study Design


Intervention

Drug:
Selinexor in combination with nivolumab and ipilimumab
Patients will commence at dose level 1. One cycle is 42 days (6 weeks) for all three agents. At dose level 1, selinexor will be dosedorally weekly, and nivolumab at 2 weekly + ipilimumab 1mg/kg 6 weekly. Patients can have dosing interruptions or reductions of any drug independently of one another, depending on the drug causing the toxicity

Locations

Country Name City State
Singapore National University Hospital, Singapore Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Galon J, Bruni D. Approaches to treat immune hot, altered and cold tumours with combination immunotherapies. Nat Rev Drug Discov. 2019 Mar;18(3):197-218. doi: 10.1038/s41573-018-0007-y. Review. — View Citation

Tan DS, Bedard PL, Kuruvilla J, Siu LL, Razak AR. Promising SINEs for embargoing nuclear-cytoplasmic export as an anticancer strategy. Cancer Discov. 2014 May;4(5):527-37. doi: 10.1158/2159-8290.CD-13-1005. Epub 2014 Apr 17. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective disease response assessment to be made according to standard, international RECIST 1.1 criteria for solid tumors. 3 years
Primary progression free survival (PFS) the time interval from the starting date of combination treatment to the date of disease progression on treatment 3 years
Primary duration of response (DOR) is defined as the time from documentation of tumor response to disease progression 3 years
Primary Duration of stable disease is defined as the time from first RECIST assessment scan documenting stable disease by RECIST criteria, to disease progression 3 years
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