Trial · NCT03073525
A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
NCT03073525, Phase 2, Completed, Gradalis, Inc.; results first posted 2023-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers. Trials, record NCT03073525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03073525
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
- NCT number
- NCT03073525
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Gradalis, Inc.
- Conditions
- Advanced Gynecological Cancers, Ovarian Cancer, Cervical Cancer, Uterine Cancer
- Interventions
- Vigil, Atezolizumab
- First posted
- 2017-03-08
- Last updated
- 2023-04-05
- Results first posted
- 2023-04-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-emergent AEs of Vigil + Atezolizumab | AEs reported from first treatment dose and up to 30 days after last treatment, about 12 months. | The safety evaluation included Adverse Events (AEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs) and changes from baseline in laboratory evaluations, vital signs, electrocardiograms and physical examinations. AEs were graded according to the National Cancer Institute (NCI) CTCAE v4.03 and coded using the Medical Dictionary for Regulatory Activities. Laboratory abnormalities were graded according to the NCI CTCAE v4.03, if applicable. |
| Secondary | Immune Response Rate | Up to 30 days after last treatment | Whole blood for correlative studies will be obtained at baseline, at the start of cycle 3 (the first cycle of combination therapy), every 3 cycles thereafter and end of treatment. |
| Secondary | Time to Progression | From baseline (prior to treatment) up to 3 years | Overall assessment of time to progression and survival will be measured by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. In Part 1, disease progression was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter. |
| Secondary | Radiographic Overall Response Rate (ORR) | From first dose to end of study treatment (up to 9 months) | Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by investigators using RECIST 1.1. In Part 1, ORR was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter. 95% confidence interval from exact binomial distribution (Blopper-Pearson method). |
| Secondary | Overall Survival (OS) | OS will be evaluated from time of randomization up to 37 months following documented disease progression. | OS is defined as time of randomization to date of death due to any cause. |
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 | Number of Treatment-emergent AEs of Vigil + Atezolizumab | AEs reported from first treatment dose and up to 30 days after last treatment, about 12 months. | Grade 3/4 treatment-related events from first dose up to 30 days after last treatment. | adverse events | NUMBER |
| SECONDARY | Immune Response Rate | Up to 30 days after last treatment | Samples were not analyzed for immune response data. | ||
| SECONDARY | Time to Progression | From baseline (prior to treatment) up to 3 years | All treated participants | months | MEDIAN |
| SECONDARY | Radiographic Overall Response Rate (ORR) | From first dose to end of study treatment (up to 9 months) | All treated participants | percentage of participants with response | NUMBER |
| SECONDARY | Overall Survival (OS) | OS will be evaluated from time of randomization up to 37 months following documented disease progression. | All treated participants. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 1: Vigil + Atezo | Grade 4 Atezolizumab-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Vigil Then Vigil + Atezo | Grade 4 Atezolizumab-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Atezo Then Vigil + Atezo | Grade 4 Atezolizumab-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 1: Vigil + Atezo | Grade 4 Vigil-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Vigil Then Vigil + Atezo | Grade 4 Vigil-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Atezo Then Vigil + Atezo | Grade 4 Vigil-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 1: Vigil + Atezo | Grade 3 Atezolizumab-Related | 0 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Vigil Then Vigil + Atezo | Grade 3 Atezolizumab-Related | 1 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 2: Atezo Then Vigil + Atezo | Grade 3 Atezolizumab-Related | 4 | adverse events | |
| Number of Treatment-emergent AEs of Vigil + Atezolizumab | Part 1: Vigil + Atezo | Grade 3 Vigil-Related | 0 | adverse events |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Vigil + Atezo | 3 | |
| Overall Study | STARTED | Part 2: Vigil Then Vigil + Atezo | 11 | |
| Overall Study | STARTED | Part 2: Atezo Then Vigil + Atezo | 10 | |
| Overall Study | Part 3: Atezolizumab Alone | Part 1: Vigil + Atezo | 0 | |
| Overall Study | Part 3: Atezolizumab Alone | Part 2: Vigil Then Vigil + Atezo | 1 | |
| Overall Study | Part 3: Atezolizumab Alone | Part 2: Atezo Then Vigil + Atezo | 0 | |
| Overall Study | COMPLETED | Part 1: Vigil + Atezo | 3 | |
| Overall Study | COMPLETED | Part 2: Vigil Then Vigil + Atezo | 11 | |
| Overall Study | COMPLETED | Part 2: Atezo Then Vigil + Atezo | 7 | |
| Overall Study | NOT COMPLETED | Part 1: Vigil + Atezo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events560
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 | Anemia | Blood and lymphatic system disorders | Part 1: Vigil + Atezo | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Part 2: Vigil | 2 | 11 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Part 2: Atezo | 2 | 10 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Part 2: Vigil and Atezo | 2 | 21 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Part 3: Atezo | 0 | 1 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1: Vigil + Atezo | 0 | 3 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 2: Vigil | 0 | 11 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 2: Atezo | 1 | 10 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 2: Vigil and Atezo | 0 | 21 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 3: Atezo | 0 | 1 | 0 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Vigil + Atezo | 3 | 3 |
| Total, all-cause mortality | Part 2: Vigil | 2 | 11 |
| Total, all-cause mortality | Part 2: Atezo | 3 | 10 |
| Total, all-cause mortality | Part 2: Vigil and Atezo | 9 | 21 |
| Total, all-cause mortality | Part 3: Atezo | 1 | 1 |
| Total, other adverse events | Part 1: Vigil + Atezo | 2 | 3 |
| Total, other adverse events | Part 2: Vigil | 9 | 11 |
| Total, other adverse events | Part 2: Atezo | 10 | 10 |
| Total, other adverse events | Part 2: Vigil and Atezo | 15 | 21 |
| Total, other adverse events | Part 3: Atezo | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers8
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03073525
GET https://conductscience.org/api/trials/v1/NCT03073525/results?page=2