Trial · NCT03217747
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
NCT03217747, Phase 1, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2025-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies. Trials, record NCT03217747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03217747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
- NCT number
- NCT03217747
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 173 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Refractory Malignant Solid Neoplasm, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Interventions
- Avelumab, Ivuxolimab, Radiation Therapy, Utomilumab
- First posted
- 2017-07-14
- Last updated
- 2026-10-23
- Results first posted
- 2025-10-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | DLT was assessed during the first 2 cycles or 8 weeks (56 days) since C1D1 of treatment. | DLTs were adverse events (AEs) related to study drug in the first 2 cycles and fulfilled one of the following * Discontinuation due to drug and/or XRT-related toxicity before DLT period ends * Delay \>28 days in receiving the next cycle due to drug and/or XRT-related toxicity * Hematologic * Gr4 neutropenia ≥7 days * Febrile neutropenia * Gr ≥3 thrombocytopenia associated with bleeding, or Gr 4 thrombocytopenia * Gr 4 anemia * Non-hematologic * Gr ≥3 nausea/vomiting or diarrhea ≥72 hours despite optimal supportive medications * Gr ≥3 fatigue ≥7 days * Gr≥2 pneumonitis ≥7 days despite corticosteroids * Gr≥3 rash ≥7 days despite treatment * Gr≥3 immune related toxicities ≥7 days despite corticosteroids * Any other Gr≥3 non-hematological toxicity (except for asymptomatic electrolytes abnormalities or hair loss which is not dose-limiting) * Gr≥3 AST, ALT, or total bilirubin elevation ≥7 days. Delay of treatment \> 14 days due to non-hematologic toxicity |
| Secondary | Objective Response Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) using CT, MRI,or PET-CT scan: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
| Secondary | Objective Response Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per Immune-related Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) using CT, MRI,or PET-CT scan: Immune-related Complete Response (irCR),Disappearance of all target lesions; Immune-related Partial Response (irPR), \>=30% decrease in the sum of the longest diameter of target and new lesions; OR = irCR + irPR. |
| Secondary | Clinical Benefit Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; Stable Disease (SD), Neither PR nor PD; Clinical benefit (CB) = CR + PR + SD ≥6 months. |
| Secondary | Clinical Benefit Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, \>=30% decrease in the sum of the longest diameter of target and new lesions; Immune-related Progressive Disease (irPD), Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; Immune-related Stable Disease (irSD), Neither irPR nor irPD; Clinical benefit (CB) = irCR + irPR + irSD ≥6 months. |
| Secondary | Disease Control Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, \>=30% decrease in the sum of the longest diameter of target lesions; PD, Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; SD, Neither PR nor PD; Disease control (DC) = CR + PR + SD. |
| Secondary | Disease Control Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, \>=30% decrease in the sum of the longest diameter of target and new lesions; irPD, Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; irSD, Neither irPR nor irPD; Disease control (DC) = irCR + irPR + irSD. |
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 | Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | DLT was assessed during the first 2 cycles or 8 weeks (56 days) since C1D1 of treatment. | All enrolled patients who received at least one dose of each study medication in the assigned treatment combination were evaluable for DLT. Patients who missed any doses during the DLT period for reasons unrelated to study drug and patients who are lost to follow-up due to reasons unrelated to treatment related AEs are not evaluable for DLT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable . In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate Per RECIST v1.1 | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable . In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate Per irRECIST | At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years. | All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group98
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 Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm A Exp Avelumab Starting From C1D15 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm A Exp Avelumab Starting From C3D1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm B Exp Avelumab Starting From C1D15 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm B Exp Avelumab Starting From C3D1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm C Escalation Avelumab Starting From C1D1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm C Exp Avelumab Starting From C1D15 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm C Exp Avelumab Starting From C3D1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria) | Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3 | 0 | Participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A Exp Avelumab Starting From C1D15 | 16 | |
| Overall Study | STARTED | Arm A Exp Avelumab Starting From C3D1 | 8 | |
| Overall Study | STARTED | Arm B Exp Avelumab Starting From C1D15 | 16 | |
| Overall Study | STARTED | Arm B Exp Avelumab Starting From C3D1 | 12 | |
| Overall Study | STARTED | Arm C Escalation Avelumab Starting From C1D1 | 4 | |
| Overall Study | STARTED | Arm C Exp Avelumab Starting From C1D15 | 17 | |
| Overall Study | STARTED | Arm C Exp Avelumab Starting From C3D1 | 11 | |
| Overall Study | STARTED | Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11 | 4 | |
| Overall Study | STARTED | Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1 | 3 | |
| Overall Study | STARTED | Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3 | 7 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events3,010
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 | Arm A Exp Avelumab Starting From C1D15 | 1 | 16 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm A Exp Avelumab Starting From C3D1 | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm B Exp Avelumab Starting From C1D15 | 1 | 16 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm B Exp Avelumab Starting From C3D1 | 0 | 12 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Escalation Avelumab Starting From C1D1 | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Exp Avelumab Starting From C1D15 | 1 | 17 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm C Exp Avelumab Starting From C3D1 | 0 | 11 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11 | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1 | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3 | 0 | 7 | 0 |
1 to 10 of 3,010Source ClinicalTrials.gov
See all 3,010 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A Exp Avelumab Starting From C1D15 | 15 | 16 |
| Total, all-cause mortality | Arm A Exp Avelumab Starting From C3D1 | 6 | 8 |
| Total, all-cause mortality | Arm B Exp Avelumab Starting From C1D15 | 13 | 16 |
| Total, all-cause mortality | Arm B Exp Avelumab Starting From C3D1 | 10 | 12 |
| Total, all-cause mortality | Arm C Escalation Avelumab Starting From C1D1 | 3 | 4 |
| Total, all-cause mortality | Arm C Exp Avelumab Starting From C1D15 | 15 | 17 |
| Total, all-cause mortality | Arm C Exp Avelumab Starting From C3D1 | 9 | 11 |
| Total, all-cause mortality | Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11 | 4 | 4 |
| Total, all-cause mortality | Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1 | 3 | 3 |
| Total, all-cause mortality | Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3 | 7 | 7 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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.
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GET https://conductscience.org/api/trials/v1/NCT03217747/results?page=2