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

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    636
  • sponsor
    ImmunityBio, Inc.
Updated on 9 June 2021
metastatic melanoma
cancer
tubal ligation
hysterectomy
systemic therapy
serum pregnancy test
measurable disease
carcinoma
treatment regimen
BRAF
metastasis
progressive disease
oxaliplatin
avelumab
fluoropyrimidine
pembrolizumab
epidermal growth factor receptor
HER2
EGFR
irinotecan
chemotherapy regimen
pd-l1
adjuvant therapy
programmed cell death 1 ligand 1
human epidermal growth factor
nivolumab
ipilimumab
durvalumab
solid tumors
cancer chemotherapy
sorafenib
adenocarcinoma
solid tumour
mek inhibitor
targeted therapy
erbb2
squamous cell carcinoma of head and neck
braf inhibitor
line of therapy
cellular therapy
transitional cell carcinoma
atezolizumab
platinum-based chemotherapy
metastatic urothelial carcinoma
immunomodulator
immunostimulants
metastatic cervical cancer
immunomodulators
platinum doublet
braf v600 mutation
immunologic adjuvant
braf v600e mutation
gastroesophageal junction adenocarcinoma
urothelial carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Colorectal Cancer, Disorders of cervix NOS, Microsatellite Instability, Malignant neoplasm of kidney, Rectal disorder, Neuroendocrine carcinoma, Uterine Cancer, melanoma, Transitional cell carcinoma, Renal Cell Carcinoma, skin cancer, HEPATIC NEOPLASM, Small Cell Lung Cancer, HEPATOCELLULAR CARCINOMA, Gastropathy, Gastric Cancer, Merkel cell carcinoma, Stomach Discomfort, Metastatic Melanoma, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, Mismatch Repair Deficiency, Kidney Cancer, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Renal Cell Cancer, Renal Cancer, Urothelial Carcinoma, cervical carcinoma, clear cell renal cell carcinoma, colorectal neoplasm, gastric cancers, colorectal cancers, nsclc, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, liver cell carcinoma, cancer, colorectal, colorectal tumor, tumors, colorectal, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment ALT-803 + Pembrolizumab, ALT-803 + Nivolumab, ALT-803 + Atezolizumab, ALT-803 + Avelumab, N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab, N-803 + Avelumab, N-803 + Durvalumab, N-803 + Pembrolizumab + PD-L1 t-haNK, N-803 + Nivolumab + PD-L1 t-haNK, N-803 + Atezolizumab + PD-L1 t-haNK, N-803 + Avelumab + PD-L1 t-haNK, N-803 + Durvalumab + PD-L1 t-haNK
Clinical Study IdentifierNCT03228667
SponsorImmunityBio, Inc.
Last Modified on9 June 2021

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