Trial Outcomes & Findings for QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (NCT NCT03563157)

NCT ID: NCT03563157

Last Updated: 2024-12-11

Results Overview

Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.

Results posted on

2024-12-11

Participant Flow

Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study. Eligible participants could have gone through both induction and maintenance treatment on study. All subjects were treated on the same arm and not randomized in the Phase 1b portion of the study.

Participant milestones

Participant milestones
Measure	NANT Colorectal Cancer (CRC) Vaccine A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NANT Colorectal Cancer (CRC) Vaccine A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Overall Study Progressive Disease	2

Baseline Characteristics

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Age, Continuous	58.0 years STANDARD_DEVIATION 4.24 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
SUBJECTS WITH METASTATIC CRC WHO HAVE BEEN PREVIOUSLY TREATED WITH STANDARD-OF-CARE (SOC) THERAPY	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.

Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) Treatment Emergent Adverse Events	2 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) Treatment Emergent Serious Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 4 months

Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Objective Response Rate by RECIST Version 1.1 and irRC	0 Participants

SECONDARY outcome

Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 9 months.

PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Progression Free Survival by RECIST Version 1.1 and irRC RECIST	6 Months Interval 5.0 to 7.0
Progression Free Survival by RECIST Version 1.1 and irRC irRC	6 Months Interval 3.0 to 9.0

SECONDARY outcome

Population: There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis.

DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants were assessed from screening to death.

OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Overall Survival	8 Months Interval 7.0 to 9.0

SECONDARY outcome

Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. Confirmed CR	0 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. Confirmed PR	0 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. Stable Disease	2 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. Progressive Disease	0 Participants

SECONDARY outcome

Timeframe: Assessments occurred at Baseline, Cycle 2 Day 8 (C2D8), Cycle 5 Day 1 (C5D1), at an unscheduled visit prior to end of treatment, and at end of treatment (up to 5 months). Each cycle was 28 days.

Population: The questionnaire was not completed for every patient at every visit.

PROs were assessed using the Functional Assessment of Cancer Therapy-colorectal cancer (FACT-C) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-36 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Quality of Life by Patient Reported Outcomes (PRO) Physical Well-Being - Baseline	19 score on a scale Interval 11.0 to 27.0
Quality of Life by Patient Reported Outcomes (PRO) Physical Well-Being - C2D8	24 score on a scale Interval 24.0 to 24.0
Quality of Life by Patient Reported Outcomes (PRO) Physical Well-Being - C5D1	17 score on a scale Interval 17.0 to 17.0
Quality of Life by Patient Reported Outcomes (PRO) Physical Well-Being - Unscheduled	5 score on a scale Interval 5.0 to 5.0
Quality of Life by Patient Reported Outcomes (PRO) Physical Well-Being - End of treatment	13 score on a scale Interval 7.0 to 19.0
Quality of Life by Patient Reported Outcomes (PRO) Social/Family Well-Being - Baseline	21 score on a scale Interval 19.0 to 22.0
Quality of Life by Patient Reported Outcomes (PRO) Social/Family Well-Being - C2D8	15 score on a scale Interval 15.0 to 15.0
Quality of Life by Patient Reported Outcomes (PRO) Social/Family Well-Being - C5D1	16 score on a scale Interval 16.0 to 16.0
Quality of Life by Patient Reported Outcomes (PRO) Social/Family Well-Being - Unscheduled	17 score on a scale Interval 17.0 to 17.0
Quality of Life by Patient Reported Outcomes (PRO) Social/Family Well-Being - End of treatment	19 score on a scale Interval 15.0 to 22.0
Quality of Life by Patient Reported Outcomes (PRO) Emotional Well-Being - Baseline	19 score on a scale Interval 18.0 to 20.0
Quality of Life by Patient Reported Outcomes (PRO) Emotional Well-Being - C2D8	18 score on a scale Interval 18.0 to 18.0
Quality of Life by Patient Reported Outcomes (PRO) Emotional Well-Being - C5D1	21 score on a scale Interval 21.0 to 21.0
Quality of Life by Patient Reported Outcomes (PRO) Emotional Well-Being - Unscheduled	13 score on a scale Interval 13.0 to 13.0
Quality of Life by Patient Reported Outcomes (PRO) Emotional Well-Being - End of treatment	17 score on a scale Interval 17.0 to 17.0
Quality of Life by Patient Reported Outcomes (PRO) Functional Well-Being - Baseline	17 score on a scale Interval 13.0 to 21.0
Quality of Life by Patient Reported Outcomes (PRO) Functional Well-Being - C2D8	18 score on a scale Interval 18.0 to 18.0
Quality of Life by Patient Reported Outcomes (PRO) Functional Well-Being - C5D1	14 score on a scale Interval 14.0 to 14.0
Quality of Life by Patient Reported Outcomes (PRO) Functional Well-Being - Unscheduled	5 score on a scale Interval 5.0 to 5.0
Quality of Life by Patient Reported Outcomes (PRO) Functional Well-Being - End of treatment	9 score on a scale Interval 8.0 to 9.0
Quality of Life by Patient Reported Outcomes (PRO) Additional Concerns - Baseline	24 score on a scale Interval 16.0 to 32.0
Quality of Life by Patient Reported Outcomes (PRO) Additional Concerns - C2D8	28 score on a scale Interval 28.0 to 28.0
Quality of Life by Patient Reported Outcomes (PRO) Additional Concerns - C5D1	29 score on a scale Interval 29.0 to 29.0
Quality of Life by Patient Reported Outcomes (PRO) Additional Concerns - Unscheduled	14 score on a scale Interval 14.0 to 14.0
Quality of Life by Patient Reported Outcomes (PRO) Additional Concerns - End of treatment	23 score on a scale Interval 14.0 to 31.0

SECONDARY outcome

Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.

Outcome measures

Outcome measures
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 Participants A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC irCR	0 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC irPR	0 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC irSD	2 Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC irPD	0 Participants

Adverse Events

NANT Colorectal Cancer (CRC) Vaccine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Regorafenib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NANT Colorectal Cancer (CRC) Vaccine n=2 participants at risk A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\] ETBX-011: Ad5 \[E1-, E2b-\]-CEA ETBX-021: Ad5 \[E1-, E2b-\]-\[HER2\] ETBX-051: Ad5 \[E1-, E2b-\]-Brachyury ETBX-061: Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 \[CD16.158V, ER IL-2\] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy	Regorafenib Regorafenib will be administered to subjects in this study.
Gastrointestinal disorders Intestinal obstruction	50.0% 1/2 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 6 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 6 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 6 months. The numbers of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events are zero in Regorafenib group because there are no subjects enrolled in Regorafenib group.	— 0/0 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 6 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 6 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 6 months. The numbers of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events are zero in Regorafenib group because there are no subjects enrolled in Regorafenib group.
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 6 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 6 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 6 months. The numbers of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events are zero in Regorafenib group because there are no subjects enrolled in Regorafenib group.	— 0/0 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 6 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 6 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 6 months. The numbers of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events are zero in Regorafenib group because there are no subjects enrolled in Regorafenib group.

Other adverse events

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place