Trial · NCT03941093
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
NCT03941093, Phase 3, Completed, Kyntra Bio; results first posted 2024-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer. Trials, record NCT03941093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03941093
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
- NCT number
- NCT03941093
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 284 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Pancreatic Cancer Non-resectable
- Interventions
- Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX, Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX
- First posted
- 2019-05-07
- Last updated
- 2024-11-05
- Results first posted
- 2024-11-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to approximately 5 years | Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method. |
| Secondary | Event-free Survival (EFS) | Up to approximately 5 years | The EFS endpoint was a composite time-to-event endpoint. The event being analyzed ('treatment failure') was defined as the earliest occurrence of: a) failure to achieve disease-free status locally after completion of neoadjuvant treatment and/or after surgery (that is, resection failure or progression that precludes surgery); b) local or distant recurrence, or c) death. The EFS was calculated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 5 years | The PFS was defined as time from date of randomization until disease progression or death due to any cause, whichever occurred first. PFS was calculated using the Kaplan-Meier method. Progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions and the appearance of one or more new lesions was also considered progression. |
| Secondary | Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1 | Up to approximately 5 years | Best overall objective response was defined as a complete response (CR) or partial response (PR). CR was defined as disappearance of all target or non-target lesions and normalization of tumor marker level (for non-target lesions), any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to approximately 5 years | The ITT population included all randomized participants regardless of whether or not study treatment was received. | months | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | Up to approximately 5 years | The ITT population included all randomized participants regardless of whether or not study treatment was received. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 5 years | The ITT population included all randomized participants regardless of whether or not study treatment was received. | months | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1 | Up to approximately 5 years | The ITT population included all randomized participants regardless of whether or not study treatment was received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 17.25 | 95% Confidence Interval 15.47 to 18.89 | months | |
| Overall Survival | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 17.94 | 95% Confidence Interval 14.59 to 20.34 | months | |
| Event-free Survival (EFS) | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 5.72 | 95% Confidence Interval 5.59 to 6.01 | months | |
| Event-free Survival (EFS) | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 5.78 | 95% Confidence Interval 5.62 to 6.37 | months | |
| Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 9.36 | 95% Confidence Interval 7.75 to 11.79 | months | |
| Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 9.40 | 95% Confidence Interval 7.69 to 10.84 | months | |
| Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1 | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 43 | Participants | ||
| Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1 | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 64 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 143 | |
| Overall Study | STARTED | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 141 | |
| Overall Study | Received At Least 1 Dose of Study Drug | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 142 | |
| Overall Study | Received At Least 1 Dose of Study Drug | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 141 | |
| Overall Study | COMPLETED | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 134 | |
| Overall Study | COMPLETED | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 134 | |
| Overall Study | NOT COMPLETED | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 9 | |
| Overall Study | NOT COMPLETED | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 7 |
Source ClinicalTrials.gov
Adverse events394
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 | Fatigue | General disorders | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 84 | 142 | |
| other | Fatigue | General disorders | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 76 | 141 | |
| other | Diarrhoea | Gastrointestinal disorders | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 81 | 142 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 90 | 141 | |
| other | Nausea | Gastrointestinal disorders | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 68 | 142 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 73 | 141 | |
| other | Anaemia | Blood and lymphatic system disorders | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 54 | 142 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 67 | 141 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 53 | 142 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 57 | 141 |
1 to 10 of 394Source ClinicalTrials.gov
See all 394 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 118 | 143 |
| Total, all-cause mortality | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 112 | 141 |
| Total, other adverse events | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 139 | 142 |
| Total, other adverse events | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 140 | 141 |
| Total, serious adverse events | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 75 | 142 |
| Total, serious adverse events | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 62 | 141 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1 | Trial comparisons |
| Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: deaths from any cause | Trial comparisons |
| Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: serious adverse events | Trial comparisons |
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/NCT03941093
GET https://conductscience.org/api/trials/v1/NCT03941093/events?page=2