Trial · NCT03563157
QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine
NCT03563157, Phase 1, Phase 2, Terminated, ImmunityBio, Inc.; results first posted 2024-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine. Trials, record NCT03563157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03563157
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine
- NCT number
- NCT03563157
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- Colorectal Cancer Metastatic, mCRC
- Interventions
Aldoxorubicin Hydrochloride, ALT-803, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT
- First posted
- 2018-06-20
- Last updated
- 2024-12-11
- Results first posted
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | 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days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.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 |
| Secondary | Objective Response Rate by RECIST Version 1.1 and irRC | 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. |
| Secondary | Progression Free Survival by RECIST Version 1.1 and irRC | 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. |
| Secondary | Duration of Response (DOR) by RECIST Version 1.1 and irRC | 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 confirmed disease progression, up to 4 months | 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. |
| Secondary | Overall Survival | 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. |
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | 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 confirmed disease progression, up to 4 months | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. |
| Secondary | Quality of Life by Patient Reported Outcomes (PRO) | 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. | 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. |
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | 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 confirmed disease progression, up to 4 months | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate by RECIST Version 1.1 and irRC | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival by RECIST Version 1.1 and irRC | 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. | Months | MEDIAN | |
| SECONDARY | Duration of Response (DOR) by RECIST Version 1.1 and irRC | 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 confirmed disease progression, up to 4 months | There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis. | ||
| SECONDARY | Overall Survival | Participants were assessed from screening to death. | Months | MEDIAN | |
| SECONDARY | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | 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 confirmed disease progression, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life by Patient Reported Outcomes (PRO) | 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. | The questionnaire was not completed for every patient at every visit. | score on a scale | MEDIAN |
| SECONDARY | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | 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 confirmed disease progression, up to 4 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | NANT Colorectal Cancer (CRC) Vaccine | Treatment Emergent Adverse Events | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | NANT Colorectal Cancer (CRC) Vaccine | Treatment Emergent Serious Adverse Events | 1 | Participants | |
| Objective Response Rate by RECIST Version 1.1 and irRC | NANT Colorectal Cancer (CRC) Vaccine | 0 | Participants | ||
| Progression Free Survival by RECIST Version 1.1 and irRC | NANT Colorectal Cancer (CRC) Vaccine | RECIST | 6 | Full Range 5 to 7 | Months |
| Progression Free Survival by RECIST Version 1.1 and irRC | NANT Colorectal Cancer (CRC) Vaccine | irRC | 6 | Full Range 3 to 9 | Months |
| Overall Survival | NANT Colorectal Cancer (CRC) Vaccine | 8 | Full Range 7 to 9 | Months | |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | NANT Colorectal Cancer (CRC) Vaccine | 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. | NANT Colorectal Cancer (CRC) Vaccine | 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. | NANT Colorectal Cancer (CRC) Vaccine | 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. | NANT Colorectal Cancer (CRC) Vaccine | Progressive Disease | 0 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NANT Colorectal Cancer (CRC) Vaccine | 2 | |
| Overall Study | COMPLETED | NANT Colorectal Cancer (CRC) Vaccine | 0 | |
| Overall Study | NOT COMPLETED | NANT Colorectal Cancer (CRC) Vaccine | 2 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Regorafenib | 0 | 0 | |
| other | Neutropenia | Blood and lymphatic system disorders | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 | |
| other | Neutropenia | Blood and lymphatic system disorders | Regorafenib | 0 | 0 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | NANT Colorectal Cancer (CRC) Vaccine | 1 | 2 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Regorafenib | 0 | 0 | |
| other | Vision blurred | Eye disorders | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 | |
| other | Vision blurred | Eye disorders | Regorafenib | 0 | 0 | |
| other | Nausea | Gastrointestinal disorders | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 | |
| other | Nausea | Gastrointestinal disorders | Regorafenib | 0 | 0 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 |
| Total, all-cause mortality | Regorafenib | 0 | 0 |
| Total, other adverse events | NANT Colorectal Cancer (CRC) Vaccine | 2 | 2 |
| Total, other adverse events | Regorafenib | 0 | 0 |
| Total, serious adverse events | NANT Colorectal Cancer (CRC) Vaccine | 1 | 2 |
| Total, serious adverse events | Regorafenib | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03563157
GET https://conductscience.org/api/trials/v1/NCT03563157/results?page=2