QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
Condition(s) studied
Investigational drug(s) / intervention(s)
N-803 + Pembrolizumab: Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Nivolumab: Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Atezolizumab: Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Avelumab: Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Durvalumab: Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Pembrolizumab + PD-L1 t-haNK: Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Nivolumab + PD-L1 t-haNK: Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Atezolizumab + PD-L1 t-haNK: Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Avelumab + PD-L1 t-haNK: Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Durvalumab + PD-L1 t-haNK: Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Docetaxel + Pembrolizumab: The study employs a 6-week cycle combination of: N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and pembrolizumab (200 mg IV).
N-803 + Docetaxel + Nivolumab: The study employs a 6-week cycle combination of:N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and nivolumab (240 mg IV). Nivolumab dosing may be increased to 480mg every four weeks as per the investigator's discretion.
Study summary
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to evaluate the safety and efficacy of NAI (nogapendekin alfa inbakicept) in combination with other agents like checkpoint inhibitors and cell therapies across various cancer types and treatment settings. The study includes multiple cohorts based on prior therapies and cancer types, with a focus on assessing overall response rate (ORR), overall survival (OS), and other measures of anti-tumor activity and immune response.
Eligibility
Primary outcome measure(s)
- ORR, defined as Investigator-assessed CR + PR per RECIST v1.1. — Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods
ORR reflects tumor shrinkage and is the key measure of antitumor activity. - Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ — Measured from the date of the first study-drug administration to the date of death (any cause) and followed for up to 24 months after the last dose (or until death), allowing the correlation with on-treatment ALC changes
OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Clinical Research Center | Anchorage | Alaska | |
| Genesis Cancer Center | Hot Springs | Arkansas | |
| Chan Soon-Shiong Institute for Medicine | El Segundo | California | |
| MemorialCare Health System | Fountain Valley | California | |
| Glendale Adventist Medical Center | Glendale | California | |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California | |
| Memorial Healthcare System | Hollywood | Florida | |
| Miami Cancer Institute (Baptist Health South Florida) | Miami | Florida | |
| University of Miami | Miami | Florida | |
| Horizon Oncology Associates | Lafayette | Indiana | |
| University of Iowa Holden Comprehensive Cancer Center | Iowa City | Iowa | |
| Baptist Health - Lexington | Lexington | Kentucky | |
| Baptist Health- Louisville | Louisville | Kentucky | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Henry Ford Hospital | Detroit | Michigan | |
| University of Minnesota - Masonic Cancer Center | Minneapolis | Minnesota | |
| Mercy Research Joplin | Joplin | Missouri | |
| Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center | Springfield | Missouri | |
| Washington University School of Medicine | St Louis | Missouri | |
| St. Vincent Frontier Cancer Center (SCL) | Billings | Montana | |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| University of Rochester | Rochester | New York | |
| Cleveland Clinic - Main Site | Cleveland | Ohio | |
| Mercy Clinic Oklahoma City | Oklahoma City | Oklahoma | |
| Providence Portland Medical Center | Portland | Oregon | |
| Gettysburg/Hanover Cancer Centers | Gettysburg | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| St. Francis Cancer Center/Bon Secours St. Francis Health System | Greenville | South Carolina | |
| Spartanburg Medical Center | Spartanburg | South Carolina | |
| Sanford Clinical Research | Sioux Falls | South Dakota | |
| University of Tennessee Medical Center | Knoxville | Tennessee | |
| Oncology Consultants of Houston | Houston | Texas | |
| Bon Secours Richmond | Richmond | Virginia |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03228667 on ClinicalTrials.gov ↗ ← All trials in the USA