LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of PVSRIPO and PVSRIPO in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04690699|
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: PVSRIPO Biological: Anti-PD-1 / Anti-PD-L1||Phase 1 Phase 2|
For each solid tumor cancer, a Phase 1 evaluation of the safety and tolerability of PVSRIPO monotherapy intratumoral injections will be completed prior to initiation of enrollment in the Phase 2 portion of the study where the anti-tumor efficacy of PVSRIPO in combination with anti PD 1/L1 therapy will be assessed. The goal of Phase 1 is to verify the technical feasibility of injecting the relevant site(s) of disease for each solid tumor cancer of interest without the confounding effect of concomitant anti-PD-1/L1 therapy on interpretation of the data. This portion of the study will also provide a preliminary evaluation of the antitumor efficacy of PVSRIPO monotherapy in each solid tumor cancer of interest and inform future studies.
Once a dosing regimen for PVSRIPO injections has been established in Phase 1, the Phase 2 portion of the study will open for enrollment. In this portion of the study, patients will be treated with a combination of PVSRIPO and a Food and Drug Administration (FDA)-approved anti-PD-1/L1 therapy, the choice of which will be determined based on the solid tumor cancer of interest and specified in the associated tumor specific appendix. A sufficient number of patients will be enrolled per solid tumor cancer of interest in the Phase 2 portion of the study to provide evidence that the combination arm shows a clinically meaningful benefit in overall response rate (ORR) over anti PD 1/L1 monotherapy based on comparison to historical controls in a similar patient population.
The goal of Phase 2 is to evaluate the anti-tumor efficacy of PVSRIPO in combination with anti PD 1/L1 therapy for each solid tumor cancer of interest, and to estimate the probability that the observed ORR is substantially different than that predicted for anti-PD-1/L1 monotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of PVSRIPO and PVSRIPO in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Arm 1: PVSRIPO and Anti-PD-1 / Anti-PD-L1 Therapy
Subjects will be treated with a combination of PVSRIPO and an FDA-approved anti-PD-1/PD-L1 therapy, the choice of which will be determined based on the solid tumor cancer of interest and specified in the associated tumor specific appendix.
PVSRIPO administered via intertumoral injection.
Biological: Anti-PD-1 / Anti-PD-L1
Anti-PD-1 / Anti-PD-L1 Therapy administered per package insert instructions.
- Safety and Tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE [ Time Frame: 24 months ]To evaluate the safety and tolerability of PVSRIPO administered as monotherapy and in combination with an anti-PD-1/PD-L1 therapy.
- Tumor Response measured by RECIST 1.1 [ Time Frame: 24 months ]To evaluate the tumor response to PVSRIPO administered in combination with an anti-PD-1/PD-L1 therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690699
|Contact: Kristin Orremail@example.com|
|Contact: Lisa Franklinfirstname.lastname@example.org|