A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    May 24, 2026
  • participants needed
    825
  • sponsor
    Pancreatic Cancer Action Network
Updated on 4 October 2022
ct scan
vasectomy
paclitaxel
gonadotropin
cancer
hysterectomy
measurable disease
oophorectomy
MRI
metastasis
neutrophil count
pancreatic adenocarcinoma
liver metastasis
gemcitabine
adenocarcinoma
metastatic pancreatic cancer
pdac
metastatic pancreatic adenocarcinoma
modified folfirinox

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 1st and/or 2nd line metastatic pancreatic cancer patients and determine which, if any, patients benefit from each investigational arm.

Secondary Objectives

  • To determine short and long-term safety signals of each investigational arm in pancreatic cancer patients vs. SOC.
  • To determine progression-free survival (PFS) for each investigational arm vs. SOC.
  • Rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
  • Rate of clinical benefit; duration of clinical benefit.

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 rapidly and efficiently test multiple novel drugs and combinations compared to standard of care therapy in first and second metastatic patients. Bayesian response-adaptive randomization will be used to assign patients to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.

Details
Condition Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
Treatment Gemcitabine combined with nab-paclitaxel, Dose -SM-88, Dose -mFOLFIRINOX, Dose, Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel, Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine, Drug: Dose -SM-88
Clinical Study IdentifierNCT04229004
SponsorPancreatic Cancer Action Network
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A subject will be eligible to participate in Precision PromiseSM 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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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
scan or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria In
Radiographically measurable disease of at least one site by computed tomography (CT)
Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 21-day window
prior to randomization
Able to swallow pills, capsules or tablets
Adequate organ function (lab results must be obtained within the 21-day window prior
Able to adhere to study visit schedule and other protocol requirements
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 subjects on anticoagulation therapy)
Subjects must be willing to provide protocol-mandated tissue and blood samples for
diagnostic and research purposes as a condition of enrollment into the trial
Females of childbearing potential [defined as a sexually mature woman who (1) has not
undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy
(the surgical removal of both ovaries) or (2) has 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 heterosexual contact or agree to use medical
doctor-approved contraception throughout the study without interruption while
receiving study treatment and for at least 6 months following last dose of study
treatment
Males must practice complete abstinence or agree to use a condom (even if he has
undergone a successful vasectomy) during sexual contact with a pregnant female or a
female of childbearing potential while participating in the study, during dose
interruptions and for at least 6 months following last dose of study treatment
HIV-infected subjects 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)
HBV-infected subjects 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)
Subjects with a history of hepatitis C virus (HCV) infection must have been treated
and cured. Subjects with 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)
Subjects 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
Subjects 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. Subjects receiving any active therapy for a concurrent secondary
malignancy are excluded
Subjects 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, subjects 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

Exclusion Criteria

Pre-existing peripheral neuropathy > Grade 1, as defined by CTCAE V 4.03
The inability to swallow pills, capsules or tablets
QTc > 450 msec if male and QTc > 470 msec if female
A subject will not be eligible to participate in Precision PromiseSM if any of the
Received any anti-cancer systemic therapy within 21 days (or 5 half-lives, whichever
following criteria are met
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])
Serious, non-healing wound, ulcer, or bone fracture
Known active tuberculosis infection
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
unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, and
pulmonary hypersensitivity pneumonitis
Receiving any active therapy for a concurrent secondary malignancy. Subjects with a
History of interstitial lung disease, history of slowly progressive dyspnea and
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]
Subjects 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. Subjects 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., subjects 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 Subjects 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. Subjects
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
treatment-related ≥ Grade 3 toxicity
rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are
For toxicity ≤ Grade 3, AE(s) must resolve to Grade 1 or baseline in order to be
generally killed virus vaccines and are permitted. However, intranasal influenza
considered eligible for this trial
vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not permitted)
Any significant medical condition, laboratory abnormality or psychiatric illness that
would limit the subject's ability to comply with study requirements
Subjects that discontinued previous treatment for pancreatic adenocarcinoma due to a
Subjects that have received allogenic bone marrow or solid organ transplants are
excluded
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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