NCT03197571

QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy

Withdrawn Phase 1/Phase 2 Last updated 20 February 2025

What this trial tests

Phase 1/Phase 2 trial testing avelumab in Urothelial Carcinoma. Withdrawn.

Timeline

1 December 2017

Primary endpoint
1 January 2019

28 December 2021

Quick facts

Lead sponsor	ImmunityBio, Inc.
Phase	Phase 1/Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2017
Primary completion	1 January 2019
Estimated completion	28 December 2021

Drugs / interventions tested

• avelumab (avelumab) — full drug profile →
• bevacizumab
• capecitabine (capecitabine) — full drug profile →
• cisplatin (cisplatin) — full drug profile →
• cyclophosphamide
• 5Fluorouracil (5-FU)
• fulvestrant (fulvestrant) — full drug profile →
• leucovorin (leucovorin) — full drug profile →
• nab-paclitaxel
• Lovaza
• Stereotactic Body Radiation Therapy
• ALT-803
• ETBX-011
• ETBX-021
• ETBX-051
• ETBX-061
• GI-4000
• GI-6207
• GI-6301
• haNK

Conditions studied

• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

ImmunityBio, Inc. — full company profile →

Who can join

18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
  Time frame: 1 year
  Phase 1b primary endpoint (safety)
• Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  Time frame: 1 year
  Phase 2 primary endpoint (ORR by RECIST)
• ORR by Immune-related response criteria (irRC)
  Time frame: 1 year
  Phase 2 primary endpoint (ORR by irRC)

Sponsor's own description

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with urothelial cancer who have progressed on or after chemotherapy and anti- PD-1/PD-L1 therapy.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
   Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
2. Normalization of the tumor microenvironment by harnessing vascular and immune modulation to achieve enhanced cancer therapy.
   Choi Y, Jung K. · · 2023 · cited 100× · PMID 37907742 · DOI 10.1038/s12276-023-01114-w
3. Trial watch: DNA-based vaccines for oncological indications.
   Pierini S, Perales-Linares R, Uribe-Herranz M, Pol JG, et al · · 2017 · cited 25× · PMID 29209575 · DOI 10.1080/2162402x.2017.1398878
4. NK Cell Adoptive Immunotherapy of Cancer: Evaluating Recognition Strategies and Overcoming Limitations.
   Sanchez CE, Dowlati EP, Geiger AE, Chaudhry K, et al · · 2021 · cited 21× · PMID 33007496 · DOI 10.1016/j.bbmt.2020.09.030
5. A review of avelumab in locally advanced and metastatic bladder cancer.
   Rao A, Patel MR. · · 2019 · cited 14× · PMID 30728859 · DOI 10.1177/1756287218823485
6. Sex bias in tumor immunity: insights from immune cells.
   Tao X, Wang Y, Xiang B, Hu D, et al · · 2025 · cited 7× · PMID 40303343 · DOI 10.7150/thno.106465