Nivolumab and All-trans Retinoic Acid for Pancreatic Cancer

Sponsor
China Medical University Hospital
Study ID
NCT05482451
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Effect of Drug

Eligibility Criteria

Sex
ALL
Age
20 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab, an immune checkpoint inhibitors targeting PD-1, represents a popular treatment option for patients with cancers via immunological mechanism. However, previous studies using nivolumab alone in pancreatic cancer have failed.
  • all trans retinoic acid — DRUG
    Our previous basic studies revealed that all-trans retinoic acid repressed pancreatic adenocarcinoma cell growth and colony formation. All-trans retinoic acid represses ADAR1, a member of interferon-stimulated genes and a negative regulator of IFNs signaling. On the other hand, all-trans retinoic acid simultaneously increases PD-L1 expression for cancer cells to evade immune surveillance. Since combination of anti-PD1 antibody and all-trans retinoic acid may block self-regulating negative feedback loops of IFNs response, this therapeutic strategy may improve outcomes of pancreatic adenocarcinoma patients.

Study Details

This study is to examine the anticancer activity of the combination therapy with all-trans retinoic acid and nivolumab in patients with chemotherapy-refractory advanced or metastatic pancreatic adenocarcinoma.

Key Dates

Start date
Mar 1, 2021
Status verified
Aug 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + all-trans retinoic acid
    Nivolumab: 3mg/kg intravenously on day 1. All-trans retinoic acid (Vesanoid) 45 mg/m2 on days 1-14. The dose of Vesanoid can be increased with addition of 15 mg/m2 in next course of treatment if there is no severe adverse effects. Therefore, the dose of Vesanoid could be 60 mg/m2 from the second course, 75 mg/m2 from the third course, till the maximal dose of 150 mg/m2 if patients tolerated the treatment. The decision of dose escalation is left to in-charge physician. The treatment cycle will repeat every 2 weeks.

Primary Outcome Measure

Overall response [ Time Frame: From the date of registration until the end of treatment, up to 2 years. ]

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