NCT03554109

QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

Detailed description

Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. The neoadjuvant phase will be 18 weeks for patients enrolled in the experimental arm and 16 weeks for those enrolled in the control arm. Following the neoadjuvant phase, all subjects will undergo determination of their current response status and appropriate breast surgery and node dissection after which assessment for pCR will be conducted following completion of neoadjuvant systemic therapy. Pathologists interpreting surgical specimens for pCR assessment will be blinded to the treatment arm. All subjects, regardless of whether or not they have achieved a pCR, will then enter the postoperative phase where they will receive adjuvant treatment. A small portion of the corresponding neoadjuvant therapy, either nab-paclitaxel or paclitaxel, will be administered as adjuvant treatment postoperatively. Adjuvant treatment will continue in the postoperative phase until the subject experiences unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Leucovorin	L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
DRUG	5-Fluorouracil	5-fluoro-2,4 (1H,3H)-pyrimidinedione
DRUG	Aldoxorubicin HCl	albumin-binding prodrug of doxorubicin HCl
DRUG	nab-Paclitaxel	Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
BIOLOGICAL	GI-4000	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
BIOLOGICAL	GI-6207	CEA yeast vaccine
BIOLOGICAL	GI-6301	Brachyury yeast vaccine
DRUG	Avelumab	Avelumab
BIOLOGICAL	ALT-803	Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	haNK	NK-92 \[CD16.158V, ER IL-2\]
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUG	Doxorubicin HCL	Doxorubicin HCL
DRUG	paclitaxel	paclitaxel

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-06-01
• Completion: 2022-02-09
• First posted: 2018-06-12
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study