Metastatic Pancreatic CancerPhase 3NCT04229004
A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
A Phase 3 study testing Gemcitabine combined with nab-paclitaxel, Dose -mFOLFIRINOX and Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel in people with Metastatic Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, run by Pancreatic Cancer Action Network at 25 sites in United States.
Trial summary
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. Primary Objectives To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine combined with nab-paclitaxel, Dose -mFOLFIRINOX and Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 25 sitesUnited States
- Study dates
- 31 Jan 2020to 5 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A participant will be eligible to participate in Precision Promise if all the below inclusion criteria are met:
- Age ≥ 18 years
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) and eligible for treatment in the first line or second line settings.
- Acceptable histologies include adenosquamous carcinoma, mucinous adenocarcinoma, hepatoid carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, and undifferentiated carcinoma with osteoclast-like-cells, and adenocarcinoma. Pancreatic neuroendocrine tumors (PNET) are excluded.
- Radiographically measurable disease by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 28-day window, prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Adequate organ function (lab results must be obtained within the 28-day window prior to randomization)
- Absolute neutrophil count ≥ 1500/mm3
- Hemoglobin ≥ the lower limit of normal (LLN) or 9g/dL
- Platelets ≥ 100,000/mm3
- Serum creatinine ≤ 1.0 x upper limit normal (ULN), or calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault)
- Albumin ≥ 3.0 g/dL
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN (up to ≤ 5 x ULN in presence of liver metastasis).
- Total bilirubin ≤ 1.5 x ULN
- INR ≤ 1.5 x ULN (up to ≤ 2 x ULN for participants on anticoagulation therapy).
- Participants must be willing to provide protocol-mandated tissue and blood samples for diagnostic and research purposes as a condition of enrollment into the trial.
- Able to swallow pills, capsules or tablets.
- Able to adhere to study visit schedule and other protocol requirements.
- Participants of childbearing potential [defined as a person assigned as female at birth who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:
- Have a negative serum or urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) as verified by the study doctor within 14 days prior to randomization.
- Commit to complete abstinence from sexual contact with persons assigned as male at birth or agree to use medical doctor-approved contraception without interruption while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.
- Participants assigned as males at birth must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with persons of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.
- known HIV-infected participants on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HIV viral load test should be performed at screening and be negative (i.e., undetectable).
- Known HBV-infected participants are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HBV viral load test should be performed at screening and be negative (i.e., undetectable).
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with known HCV infection who are currently on treatment are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HCV viral load test should be performed at screening and be negative (i.e., undetectable).
- Participants with a history of brain metastases are eligible provided they show evidence of stable lesions (and no new lesions) with no evidence of tumor progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. In addition, any neurological symptoms that developed either as a result of the brain metastases or their treatment, must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed > 7 days prior to the first dose of trial therapy.
- No known leptomeningeal disease.
- Participants with a prior or concurrent malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible. Participants receiving any active therapy for a concurrent secondary malignancy are excluded.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. To be eligible for this trial, participants should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
- Understands the nature of the study and has agreed to participate by voluntarily signing the IRB approved informed consent.
Who cannot join
- A participant will not be eligible to participate in Precision Promise if any of the following criteria are met:
- Received any anti-cancer systemic therapy within 21 days (or 5 half-lives, whichever is shorter,) prior to randomization.
- Has had major surgery within 14 days prior to enrollment.
- History of known allergy or hypersensitivity to any of the study treatments or any of their excipients or contraindication to any of the study treatments as outlined in the local prescribing information (e.g., United States Prescribing Information [USPI]).
- Pre-existing peripheral neuropathy > Grade 1, as defined by CTCAE V 4.03.
- Known active tuberculosis infection.
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- Serious, non-healing wound, ulcer, or bone fracture.
- The inability to swallow pills, capsules or tablets.
- Receiving any active therapy for concurrent secondary malignancy. Participants with a prior or concurrent malignancy whose natural history and/or management does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible.
- History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, and pulmonary hypersensitivity pneumonitis.
- QTc > 450 msec if male and QTc > 470 msec if female.
- Uncontrolled or severe cardiac disease (history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the prior 6 months), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia [including atrial flutter/fibrillation].
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. Participants worse than Class 2 are excluded. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
- Active, uncontrolled infections (bacterial, viral, or fungal infection(s)) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment (i.e., Participants must be afebrile for > 48 hours off antibiotics).
- Active, known or suspected autoimmune disease, including systemic lupus erythematosus, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or autoimmune hepatitis.
- o Participants with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible to participate.
- Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications. Participants receiving replacement therapy of 10 mg of prednisone (or the equivalent hydrocortisone dose) per day are eligible.
- Receipt of live vaccines within 30 days prior to the first dose of study treatment or while on active treatment within the trial. (examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not permitted).COVID-19 vaccines are permitted.
- Any significant medical condition, laboratory abnormality or psychiatric illness that would limit the participant's ability to comply with study requirements.
- Participants that discontinued previous treatment for pancreatic adenocarcinoma due to a treatment-related ≥ Grade 3 toxicity.
- o For toxicity ≤ Grade 3, AE(s) must resolve to Grade 1 or baseline in order to be considered eligible for this trial.
- Participants that have received allogenic bone marrow or solid organ transplants are excluded.
- Participants that are pregnant, planning on becoming pregnant, or are breast feeding.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan, 48109
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Florida College of Medicine
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030-3411
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048-1804
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
New York University Langone Medical Center - Perlmutter Cancer Center
New York, New York, 10016
Evelyn H. Lauder Breast Center - Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Physicians - Solid Tumor/Gastrointestinal Oncology
New York, New York, 10065
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104-5127
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23219
Mayo Clinic Cancer Center (MCCC)
Rochester, Minnesota, 55905-0001
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Virginia Mason Hospital & Seattle Medical Center
Seattle, Washington, 98101
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, 63110-1010
About this study
Official title: Precision Promise Platform Trial for Metastatic Pancreatic Cancer
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Primary Objectives
Read more
- To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
- To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
- To determine progression-free survival (PFS) for each investigational arm vs. SOC.
- To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
- To determine rates of clinical benefit; duration of clinical benefit.
Read the detailed description
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will test multiple investigational drugs and combinations compared to standard of care therapy in first and second line metastatic participants. Bayesian response-adaptive randomization will be used to assign participants to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.
- Being tested
- Gemcitabine combined with nab-paclitaxel, Dose -mFOLFIRINOX, Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel, Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine, Drug: Dose -SM-88
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine combined with nab-paclitaxelDrug
Arm is closed to recruitment.
Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle.
If one of the chemotherapy medications is held, the other study medications may be given.
Doses should be re-adjusted if the participant's weight changes by +/- >10%. If the participant's weight changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
Dose -mFOLFIRINOXDrug
Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- >10%. If the participant's weight changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxelDrug
Arm is closed to recruitment.
Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15)
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabineDrug
Arm is closed to recruitment.
Canakinumab 250mg SC- Day 1 of every 28 day cycle
Spartalizumab 400 mg IV - Day 1 of every 28 day cycle
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Drug: Dose -SM-88Drug
Arm is closed to recruitment.
460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine combined with nab-paclitaxel | Active comparator | Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed. Receives: Drug: Gemcitabine combined with nab-paclitaxel |
| mFOLFIRINOX | Active comparator | Arm is closed to recruitment.
Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion Receives: Drug: Dose -mFOLFIRINOX |
| pamrevlumab (FibroGen) | Experimental | Arm is closed to recruitment.
Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel.
Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel.
Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines. Receives: Drug: Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel |
| Canakinumab and Spartalizumab | Experimental | Arm is closed to recruitment.
Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine.
Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine. Receives: Drug: Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine |
| Experimental: SM-88 | Experimental | Arm is closed to recruitment.
460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
All four agents (SM-88, methoxsalen, phenytoin, and sirolimus) should be dosed with approximately 240 mL (8 fl. oz.) of water in the morning. All four agents should be taken together consistently. SM-88 used with MPS should ideally be taken approximately 1 hour before or 2 hours after a meal. Receives: Drug: Drug: Dose -SM-88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival (OS) is defined from the time of initiation of treatment until death due to any cause. Participants still alive at the time of an analysis will be considered censored at their date of last contact.
Measured: 0 weeks
Secondary outcomes (5)
Progression free survival (PFS)
PFS will be presented with probability that the hazard ratio is less than 1.0 as well as the corresponding Kaplan-Meier curves and the log-rank test for the comparison with controls.
Measured: From initiation of therapy to clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.
Performance Status
Changes in Performance Status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) Performance Status, where the highest value is 0 (patient is fully active) and the lowest value is 5 (patient is deceased).
Measured: From screening through study completion, an average of 2 years.
Overall Response Rate (ORR)
ORR is defined as the portion of subjects on an arm with a tumor size reduction of at least 30%.
Measured: From initiation of treatment to clinically determined tumor size reduction for a minimum of 4 weeks
Duration of Overall Response Rate (ORR)
Duration of ORR is defined as the time from the date of response to the date of clinically determined disease progression or death due to any cause.
Measured: From date of first occurrence of a documented objective response to date of clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.
Duration of Clinical Benefit
Duration of Clinical Benefit will be evaluated using a composite of measures including patient reported outcomes (PROs), supportive care regimens, and disease status.
Measured: From screening through last dose of therapy, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start31 Jan 2020
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pancreatic Cancer Action Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229004
- Sponsor's protocol ID
- PanCAN_Precision Promise
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.
PubMed 35204752
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Promise Platform Trial for Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04229004
- Acronym / sponsor ID
- PanCAN_Precision Promise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Pancreatic Cancer Action NetworkUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Primary Objectives
- To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
- To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
- To determine progression-free survival (PFS) for each investigational arm vs. SOC.
- To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
- To determine rates of clinical benefit; duration of clinical benefit.
Detailed description
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will test multiple investigational drugs and combinations compared to standard of care therapy in first and second line metastatic participants. Bayesian response-adaptive randomization will be used to assign participants to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine combined with nab-paclitaxel | Active comparator | Drug: Gemcitabine combined with nab-paclitaxelArm is closed to recruitment. The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed. |
| mFOLFIRINOX | Active comparator | Drug: Dose -mFOLFIRINOXArm is closed to recruitment. Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion |
| pamrevlumab (FibroGen) | Experimental | Drug: Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxelArm is closed to recruitment. Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel. Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines. |
| Canakinumab and Spartalizumab | Experimental | Drug: Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabineArm is closed to recruitment. Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine. Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine. |
| Experimental: SM-88 | Experimental | Drug: Drug: Dose -SM-88Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus. All four agents (SM-88, methoxsalen, phenytoin, and sirolimus) should be dosed with approximately 240 mL (8 fl. oz.) of water in the morning. All four agents should be taken together consistently. SM-88 used with MPS should ideally be taken approximately 1 hour before or 2 hours after a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- A participant will be eligible to participate in Precision Promise if all the below inclusion criteria are met:
- Age ≥ 18 years
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) and eligible for treatment in the first line or second line settings.
- Acceptable histologies include adenosquamous carcinoma, mucinous adenocarcinoma, hepatoid carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, and undifferentiated carcinoma with osteoclast-like-cells, and adenocarcinoma. Pancreatic neuroendocrine tumors (PNET) are excluded.
- Radiographically measurable disease by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 28-day window, prior to randomization.
Key exclusion criteria (23 listed)
- A participant will not be eligible to participate in Precision Promise if any of the following criteria are met:
- Received any anti-cancer systemic therapy within 21 days (or 5 half-lives, whichever is shorter,) prior to randomization.
- Has had major surgery within 14 days prior to enrollment.
- History of known allergy or hypersensitivity to any of the study treatments or any of their excipients or contraindication to any of the study treatments as outlined in the local prescribing information (e.g., United States Prescribing Information [USPI]).
- Pre-existing peripheral neuropathy > Grade 1, as defined by CTCAE V 4.03.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine combined with nab-paclitaxelArm is closed to recruitment. Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- >10%. If the participant's weight changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines. | Drug | Gemcitabine combined with nab-paclitaxel |
| Dose -mFOLFIRINOXArm is closed to recruitment. The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- >10%. If the participant's weight changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines. | Drug | mFOLFIRINOX |
| Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxelArm is closed to recruitment. Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15) Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle | Drug | pamrevlumab (FibroGen) |
| Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabineArm is closed to recruitment. Canakinumab 250mg SC- Day 1 of every 28 day cycle Spartalizumab 400 mg IV - Day 1 of every 28 day cycle Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle | Drug | Canakinumab and Spartalizumab |
| Drug: Dose -SM-88Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus. | Drug | Experimental: SM-88 |
Primary outcome
Overall Survival
Time frame: 0 weeks
Overall survival (OS) is defined from the time of initiation of treatment until death due to any cause. Participants still alive at the time of an analysis will be considered censored at their date of last contact.
5 secondary outcomes
Progression free survival (PFS)
Time frame: From initiation of therapy to clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.
Performance Status
Time frame: From screening through study completion, an average of 2 years.
Overall Response Rate (ORR)
Time frame: From initiation of treatment to clinically determined tumor size reduction for a minimum of 4 weeks
Duration of Overall Response Rate (ORR)
Time frame: From date of first occurrence of a documented objective response to date of clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.
Duration of Clinical Benefit
Time frame: From screening through last dose of therapy, assessed up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 35204752Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine combined with nab-paclitaxel, Dose -mFOLFIRINOX and Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel in people with Metastatic Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, run by Pancreatic Cancer Action Network at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 0 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.