9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2025
  • participants needed
    32
  • sponsor
    University of Kansas Medical Center
Updated on 23 March 2022

Summary

To determine the rate of disease control of the combination of 9-ING-41 and retifanlimab plus gemcitabine/nab-paclitaxel in patients with pancreatic cancer without prior systemic therapy for advanced disease.

The researchers will be looking at how the cancer you have reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment. They want to discover if using this combination will help and is able to keep the cancer you have from progressing.

Details
Condition Pancreatic Adenocarcinoma
Treatment Gemcitabine, Abraxane, 9-ING-41, Retifanlimab
Clinical Study IdentifierNCT05239182
SponsorUniversity of Kansas Medical Center
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
Is aged ≥ 18 years
Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting
Must have at least 1 measurable lesion per RECIST v1.1. Lesions that are radiated should not count as target lesions unless there is evidence of growth post radiation on a subsequent scan prior to trial enrollment
Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1000/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL
Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 2.5 x ULN (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells); bilirubin ≤ 1.5 x ULN
Adequate renal function: creatinine clearance CrCl > 60 mL/min measured or calculated by Cockcroft- Gault (C-G) equation (estimated glomerular filtration rate [eGFR] can also be used in place of CrCl)
Serum amylase and lipase ≤ 1.5 x ULN
Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0 - 1
Has received the final dose of any of the following treatments/ procedures within the specified minimum intervals before first dose of study drug: Focal radiation therapy - 7 days Surgery with general anesthesia - 7 days Surgery with local anesthesia - 7 days

Exclusion Criteria

Is pregnant or lactating
Is known to be hypersensitive to any of the components or metabolites of 9-ING-41 or to the excipients used in its formulation, or known sensitivity to one of the chemotherapeutic agents or to the PD-1 inhibitor
History of receiving prior treatment with any anti-PD-1, PD-L1 or PD-L2 agent
Has endocrine or acinar pancreatic carcinoma
Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, anemia not requiring transfusion support and infertility. Recovery is defined as ≤ Grade 1 or baseline severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)
Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia requiring medical treatment detected at screening
Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator
Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI). Patients with stable brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered)
Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation
Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial
Has a current malignancy other than pancreatic cancer
Known immunodeficiency syndrome or active autoimmune disease or requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent)
Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis
Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy that is > 30 Gy within 6 months of the first dose of study treatment
Has received systemic antibiotics ≤ 7 days prior to the first dose of study drug
History of organ transplant, including allogeneic stem cell transplantation
Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids)
Known allergy or hypersensitivity to any component of retifanlimab or formulation components
Has received a live vaccine within 28 days of the planned start of study drug
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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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