ACTIVE_NOT_RECRUITING

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

Quick Facts

Study Start:2018-12-11
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03228667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Alaska Clinical Research Center
Anchorage, Alaska, 99530
United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913
United States
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
United States
MemorialCare Health System
Fountain Valley, California, 37846
United States
Glendale Adventist Medical Center
Glendale, California, 91206
United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
Miami Cancer Institute (Baptist Health South Florida)
Miami, Florida, 33176
United States
University of Miami
Miami, Florida, 33180
United States
Horizon Oncology Associates
Lafayette, Indiana, 47905
United States
University of Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
Baptist Health - Lexington
Lexington, Kentucky, 40503
United States
Baptist Health- Louisville
Louisville, Kentucky, 40207
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Mercy Research Joplin
Joplin, Missouri, 64804
United States
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, 65804
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
St. Vincent Frontier Cancer Center (SCL)
Billings, Montana, 59102
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
University of Rochester
Rochester, New York, 14642
United States
Cleveland Clinic - Main Site
Cleveland, Ohio, 44195
United States
Mercy Clinic Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Gettysburg/Hanover Cancer Centers
Gettysburg, Pennsylvania, 17325
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
St. Francis Cancer Center/Bon Secours St. Francis Health System
Greenville, South Carolina, 29607
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
Sanford Clinical Research
Sioux Falls, South Dakota, 57104
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Oncology Consultants of Houston
Houston, Texas, 77024
United States
Bon Secours Richmond
Richmond, Virginia, 23114
United States

Collaborators and Investigators

Sponsor: ImmunityBio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-11
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2018-12-11
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Pembrolizumab
  • Nivolumab
  • Non-Small Cell Lung Cancer (NSCLC)
  • Immunotherapy
  • Interleukin-15
  • PD-1 Checkpoint Inhibitor
  • ALT-803
  • Atezolizumab
  • Avelumab
  • Small Cell Lung Cancer (SCLC)
  • Urothelial Carcinoma
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Merkel Cell Carcinoma (MCC)
  • Melanoma
  • Renal Cell Carcinoma (RCC)
  • Gastric Cancer
  • Cervical Cancer
  • Hepatocellular Carcinoma (HCC)
  • Microsatellite Instability-High (MSI-H)
  • PD-L1 Checkpoint Inhibitor
  • Mismatch Repair Deficient (dMMR) Solid Tumor Cancer
  • Colorectal Cancer (CRC)
  • Durvalumab
  • PD-L1 t-haNK
  • N-803
  • Keytruda
  • Opdivo
  • Imfinzi
  • Bavencio
  • Tecentriq

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Urothelial Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Melanoma
  • Renal Cell Carcinoma
  • Gastric Cancer
  • Cervical Cancer
  • Hepatocellular Carcinoma
  • Microsatellite Instability
  • Mismatch Repair Deficiency
  • Colorectal Cancer