Trial · NCT03990571
Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
NCT03990571, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma. Trials, record NCT03990571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03990571
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
- NCT number
- NCT03990571
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Metastatic Adenoid Cystic Carcinoma, Progressive Disease, Recurrent Adenoid Cystic Carcinoma
- Interventions
- Avelumab, Axitinib
- First posted
- 2019-06-19
- Last updated
- 2024-10-18
- Results first posted
- 2024-08-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Objective Response Rate (ORR) to Axitinib and Avelumab Combination According to RECIST 1.1 Criteria. | Up to 33 months | All eligible patients who received at least one cycle of treatment and had at least one restaging image were considered evaluable for the primary end point. Objective response includes complete response (CR) + partial response (PR). Radiographic imaging for tumor assessment was performed at baseline and then every 8 weeks. |
| Secondary | Estimate Median Progression-free Survival, Median Overall Survival | up to 40 months | Progression-free survival (PFS) was defined as the duration from start of treatment to date of progression or death, whichever occurred first. Overall survival (OS) was defined as the duration from start of treatment to death. The Kaplan-Meier approach was used to estimate the PFS and OS distributions, along with median estimates with 95% CI. |
| Secondary | Estimate Progression Free Survival Rate at 6 Months After Start of Treatment, Overall Survival Rate 6 Months After Start of Treatment | completed at 6 months from start of treatment | Progression-free survival (PFS) was defined as the duration from start of treatment to date of progression or death, whichever occurred first. The PFS rate at 6-month was the percentage of patients without disease progression at 6 months. Overall survival (OS) was defined as the duration from start of treatment to death. The OS rate at 6-month was the percentage of living patients at 6 months. The Kaplan-Meier approach was used to estimate the PFS and OS distributions, along with median estimates with 95% CI. |
| Secondary | Estimate Duration of Response | Up to 30 months | Duration of response (DoR) was measured from the date response criteria were met until the first date that progression was documented. The Kaplan-Meier approach was used to estimate the DOR distributions, along with median estimates with 95% CI. |
| Secondary | Evaluate Safety and Toxicity | Up to 30 months | Evaluated for the number of incidences for safety and toxicity for treatment related adverse events that occurred in \> 10% of patients and all grade 3 or higher treatment related adverse events. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess the Objective Response Rate (ORR) to Axitinib and Avelumab Combination According to RECIST 1.1 Criteria. | Up to 33 months | 40 participants enrolled from July 2019 to June 2021 (6 were screen failures), 34 were treated and 6 of the 34 were evaluable for safety only and did not undergo the first re-staging imaging assessment. | percentage of participants | NUMBER |
| SECONDARY | Estimate Median Progression-free Survival, Median Overall Survival | up to 40 months | Forty patients enrolled from July 2019 to June 2021 (6 were screen failures), 34 were treated and 6 of the 34 were evaluable for safety only and did not undergo any re-staging imaging assessment, 28 were evaluable for time-to-event outcomes. | months | MEDIAN |
| SECONDARY | Estimate Progression Free Survival Rate at 6 Months After Start of Treatment, Overall Survival Rate 6 Months After Start of Treatment | completed at 6 months from start of treatment | Forty patients enrolled from July 2019 to June 2021 (6 were screen failures), 34 were treated and 6 of the 34 were evaluable for safety only and did not undergo any re-staging imaging assessment, 28 were evaluable for time-to-event outcomes. | percentage of participants | NUMBER |
| SECONDARY | Estimate Duration of Response | Up to 30 months | Forty patients enrolled from July 2019 to June 2021 (6 were screen failures), 34 were treated and 6 of the 34 were evaluable for safety only and did not undergo any re-staging imaging assessment, 28 were evaluable for objective response and time-to-event outcomes. Five patients achieved confirmed partial response. | months | MEDIAN |
| SECONDARY | Evaluate Safety and Toxicity | Up to 30 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assess the Objective Response Rate (ORR) to Axitinib and Avelumab Combination According to RECIST 1.1 Criteria. | Treatment (Axitinib, Avelumab) | 18 | 95% Confidence Interval 6.1 to 36.9 | percentage of participants | |
| Estimate Median Progression-free Survival, Median Overall Survival | Treatment (Axitinib, Avelumab) | PFS | 7.3 | 95% Confidence Interval 3.7 to 11.2 | months |
| Estimate Median Progression-free Survival, Median Overall Survival | Treatment (Axitinib, Avelumab) | OS | 16.6 | 95% Confidence Interval 12.4 to NA | months |
| Estimate Progression Free Survival Rate at 6 Months After Start of Treatment, Overall Survival Rate 6 Months After Start of Treatment | Treatment (Axitinib, Avelumab) | PFS rate at 6-month | 57 | 95% Confidence Interval 41.5 to 78.8 | percentage of participants |
| Estimate Progression Free Survival Rate at 6 Months After Start of Treatment, Overall Survival Rate 6 Months After Start of Treatment | Treatment (Axitinib, Avelumab) | OS rate at 6-month | 86 | 95% Confidence Interval 73.7 to 99.7 | percentage of participants |
| Estimate Duration of Response | Treatment (Axitinib, Avelumab) | 11 | 95% Confidence Interval 5.5 to NA | months | |
| Evaluate Safety and Toxicity | Treatment (Axitinib, Avelumab) | Adverse Events | 34 | Participants | |
| Evaluate Safety and Toxicity | Treatment (Axitinib, Avelumab) | Serious Adverse Events | 7 | Participants | |
| Evaluate Safety and Toxicity | Treatment (Axitinib, Avelumab) | Labs | 19 | Participants | |
| Evaluate Safety and Toxicity | Treatment (Axitinib, Avelumab) | Deaths | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Axitinib, Avelumab) | 34 | |
| Overall Study | COMPLETED | Treatment (Axitinib, Avelumab) | 28 | |
| Overall Study | NOT COMPLETED | Treatment (Axitinib, Avelumab) | 6 |
Source ClinicalTrials.gov
Adverse events128
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 pain | Gastrointestinal disorders | Treatment (Axitinib, Avelumab) | 2 | 34 | 2 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Axitinib, Avelumab) | 5 | 34 | 8 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Axitinib, Avelumab) | 2 | 34 | 3 |
| other | Allergic reaction | Investigations | Treatment (Axitinib, Avelumab) | 2 | 34 | 2 |
| other | Anemia | Investigations | Treatment (Axitinib, Avelumab) | 4 | 34 | 6 |
| other | Anorexia | Investigations | Treatment (Axitinib, Avelumab) | 7 | 34 | 8 |
| other | Anxiety | Investigations | Treatment (Axitinib, Avelumab) | 1 | 34 | 1 |
| other | Arthralgia | Investigations | Treatment (Axitinib, Avelumab) | 1 | 34 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Treatment (Axitinib, Avelumab) | 1 | 34 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Axitinib, Avelumab) | 5 | 34 | 5 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Axitinib, Avelumab) | 1 | 34 |
| Total, other adverse events | Treatment (Axitinib, Avelumab) | 31 | 34 |
| Total, serious adverse events | Treatment (Axitinib, Avelumab) | 7 | 34 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36898078 | DERIVED |
Source PubMed
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.
GET https://conductscience.org/api/trials/v1/NCT03990571
GET https://conductscience.org/api/trials/v1/NCT03990571/events?page=2