Trial · NCT06757244
DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
NCT06757244, Phase 2, Recruiting, Hopital Foch
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer. Trials, record NCT06757244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06757244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
- NCT number
- NCT06757244
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 35 participants, estimated
- Lead sponsor
- Hopital Foch
- Conditions
- Pancreas Neoplasms
- Interventions
- Dostarlimab, Vitamin D3 (Cholecalciferol), mFOLFIRINOX Treatment Regimen, LV5FU2
- First posted
- 2025-01-03
- Last updated
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease | 24 months | The proportion of patients with an objective response at the completion of their follow-up (truncated at 24 months), among all eligible patients. An objective response will be defined as the best overall response of complete response (CR) or partial response (PR) assessed by investigators using validated criteria (i.e. RECIST 1.1) |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0. | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The number and percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. TEAEs are defined as adverse events occurring after the initiation of study treatment and before 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, must be reported by the investigator, or an already present event that worsens in intensity or frequency following the treatment. TEAEs will be categorized by type (serious or non-serious; expected or unexpected) and severity (CTCAE grades 1 to 5) as per investigator assessment |
| Secondary | Incidence of participants with adverse events of special interest (AESIs) as assessed by CTCAE v5.0. | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The number and percentage of participants experiencing at least one adverse events of special interest (AESIs) will be summarized. AESIs are pre-defined events requiring detailed monitoring and rapid communication by the investigator due to their potential association with the investigational product. The severity of AESIs will be graded using CTCAE v5.0 (CTCAE grades 1 to 5). |
| Secondary | Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry, Thyroid Function and Urinalysis Lab Parameters | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | Blood and urine samples will be collected to evaluate hematology, clinical chemistry, thyroid function and urinalysis lab parameters . Changes from baseline to post-baseline visits will be computed. Final values and changes from baseline in continuous variables will be described et each visit. Clinically significant laboratory abnormalities (as defined by CTCAE v5.0 criteria) will also be reported. |
| Secondary | Number of Participants With AEs Leading to Death | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | Number of participants with TEAEs leading to death will be assessed. |
| Secondary | Median Progression Free Survival (mPFS) in months | 24 months | The median PFS will be assessed as the time after which half of the patients are progression-free and alive. |
| Secondary | Median Overall Survival (mOS) in months | 24 months | The median OS will be assessed as the time after which half of the patients are alive. |
| Secondary | Median Duration of Response (mDOR) in months | 24 months | the time from onset of first response (PR or CR as defined above) to progression or death due to any reason, whichever occurs first |
| Secondary | Number of Participants With Immune Related Adverse Events (irAEs) | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The irAEs are events which may be severe or fatal according to CTCAE v5.0 and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including dostarlimab While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. |
| Secondary | Clinical benefit rate according to RECIST 1.1 (CBR) | 24 months | the proportion of patients with the Best Overall Response equal to Complete Response, Partial Response or Stable Disease, among all eligible patients. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06757244
GET https://conductscience.org/api/trials/v1/NCT06757244/registered