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

Colorectal Cancer Clinical Trial

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

Clinical Trial Summary

This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N-803, and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Merkel Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell
  • Cervical Cancer
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Lung Neoplasms
  • Melanoma
  • Merkel Cell Carcinoma
  • Microsatellite Instability
  • Mismatch Repair Deficiency
  • Non-Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Stomach Neoplasms
  • Urothelial Carcinoma
  • Uterine Cervical Neoplasms
Clinical Trial Details
NCT number NCT03228667
Study type Interventional
Source ImmunityBio, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 11, 2018
Completion date December 2024
View Details
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