Trial · NCT03493945
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
NCT03493945, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1). Trials, record NCT03493945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03493945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
- NCT number
- NCT03493945
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Neoplasm, Advanced Solid Tumor, Solid Tumor, Non-metastatic Castration-resistant Prostate Cancer
- Interventions
- M7824, N-803, MVA-BN-Brachyury, FPV-Brachyury, Epacadostat, Acetaminophen, Ibuprofen, Naproxen, Benadryl, EKG, Bone scan, CT chest, abdomen and pelvis, MRI
- First posted
- 2018-04-11
- Last updated
- 2025-09-30
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | From enrollment up to 49 weeks | Objective clinical response and/or prostate-specific antigen (PSA) decline of \>=30% sustained for a minimum of 21 days. Any of these is considered 'clinical benefit.' Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat. |
| Primary | Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | From enrollment up to 49 weeks | Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat. |
| Primary | Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT) | Within 21 days of the start of treatment | A DLT is defined as any of the following adverse events (AE) possibly related to study drugs that occur within 21 days of the start of treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is moderate. Grade 4 is life-threatening, and Grade 5 is death related to AE. A DLT is any grade ≥ 4 hematologic toxicity or grade 3 thrombocytopenia with associated bleeding; any grade ≥ 3 non-hematologic toxicity, except for any of the following: transient (≤ 48 hour) grade 3 fatigue, local reactions, flu-like symptoms, fever, headache, or nausea, emesis, and diarrhea; or CTCAE Grade 3 skin toxicity lasting less than five days. A non-serious AE is any untoward medical occurrence. A serious AE is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect. |
| Secondary | 6-month Progression Free Survival (PFS) Probability | 6-months | 6-month progression free survival was measured from the on-study date until progression or death without progression in participants and reported with a 95% confidence interval. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. |
| Secondary | Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803) | 3 weeks dose-limiting toxicity (DLT) period | Number of participants with grades 1, 2, 3, and 4 non-serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803). |
| Secondary | Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803) | 3 weeks dose-limiting toxicity (DLT) period | Number of participants with grades 3 4, and/or 5 serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803). |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | From enrollment up to 49 weeks | 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments. | Proportion of participants | NUMBER |
| PRIMARY | Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | From enrollment up to 49 weeks | 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible, and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments. | Proportion of participants | NUMBER |
| PRIMARY | Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT) | Within 21 days of the start of treatment | 58/59 participants were analyzed because 1 was ineligible. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 6-month Progression Free Survival (PFS) Probability | 6-months | 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible, and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments. | proportion probability | MEDIAN |
| SECONDARY | Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803) | 3 weeks dose-limiting toxicity (DLT) period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803) | 3 weeks dose-limiting toxicity (DLT) period | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks. | 58/59 participants were analyzed because one was deemed ineligible. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2,442
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | .076 | 80% Confidence Interval 0.0081 to 0.268 | Proportion of participants | |
| Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion | 0.292 | 80% Confidence Interval 0.170 to 0.442 | Proportion of participants | |
| Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | 0 | 80% Confidence Interval 0.000 to 0.319 | Proportion of participants | |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Complete Response | 0 | 95% Confidence Interval 0.000 to 0.708 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion | Complete Response | 0 | 95% Confidence Interval 0.000 to 0.459 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Complete Response | 0 | 95% Confidence Interval 0.000 to 0.975 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Partial Response | 0 | 95% Confidence Interval 0.000 to 0.708 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion | Partial Response | 0.33 | 95% Confidence Interval 0.0433 to 0.777 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Partial Response | 0 | 95% Confidence Interval 0.000 to 0.975 | Proportion of participants |
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Stable Disease | 0.33 | 95% Confidence Interval 0.0084 to 0.906 | Proportion of participants |
1 to 10 of 2,442Source ClinicalTrials.gov
See all 2,442 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I Dose Escalation | STARTED | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 4 | |
| Phase I Dose Escalation | STARTED | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 10 | |
| Phase I Dose Escalation | STARTED | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | 1 | |
| Phase I Dose Escalation | STARTED | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 0 | |
| Phase I Dose Escalation | STARTED | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 0 | |
| Phase I Dose Escalation | STARTED | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | 0 | |
| Phase I Dose Escalation | STARTED | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | 0 | |
| Phase I Dose Escalation | COMPLETED | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 4 | |
| Phase I Dose Escalation | COMPLETED | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 9 | |
| Phase I Dose Escalation | COMPLETED | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events1,842
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 | Abdominal distension | Gastrointestinal disorders | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 0 | 10 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 0 | 13 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 0 | 13 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | 1 | 12 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 4 | 10 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 5 | 13 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 2 | 13 | 2 |
1 to 10 of 1,842Source ClinicalTrials.gov
See all 1,842 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 1 | 4 |
| Total, all-cause mortality | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 2 | 10 |
| Total, all-cause mortality | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 1 | 13 |
| Total, all-cause mortality | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 0 | 13 |
| Total, all-cause mortality | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | 0 | 12 |
| Total, all-cause mortality | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | 0 | 6 |
| Total, other adverse events | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 4 | 4 |
| Total, other adverse events | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 10 | 10 |
| Total, other adverse events | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 13 | 13 |
| Total, other adverse events | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 13 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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