A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy

Part of paid clinical trials in Middletown, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04666740
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Homologous Recombination Deficiency (HRD)
  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV every 3 week. After the first 6 months (8 cycles), on C9D1 Pembrolizumab 400 mg IV every 6 week.
  • Olaparib — DRUG
    Olaparib 300 mg twice day orally daily continuously (POLAR) as a maintenance therapy. After the first 6 months (8 cycles), on C9D1 olaparib 300 mg twice a day orally will be continued.

Study Details

The study researchers think that combining the drugs pembrolizumab and olaparib (POLAR) may help people with this disease because pembrolizumab activates the immune system to fight cancer, and olaparib destroys cancer cells by preventing them from repairing damage to the genetic information that helps them survive and grow. The study researchers are doing this study to find out whether combining these drugs may be a more effective treatment for this cancer than taking olaparib alone.

Key Dates

Start date
Dec 18, 2020
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Core HRD
    Patients with either pathogenic germline or somatic alterations of 3 core homologous recombination-genes (HR-genes) - (BRCA1/2, or PALB2) who have stable or responding disease on first-line or second-line platinum therapy in two consecutive imaging assessments over at least 4 months are eligible for inclusion in Cohort A.
  • Experimental: Cohort B: Non core HRD
    Patients with either pathogenic somatic or germline non-core 14 HR-gene alterations (ATM, BAP1, BARD1, BLM, BRIP1, CHEK2, FAM175A, FANCA, FANCC, NBN, RAD50, RAD51, RAD51C, RTEL1) who have stable or responding disease on first-line or second-line platinum therapy in two consecutive imaging assessments over at least 4 months are eligible for inclusion in Cohort B.
  • Experimental: Cohort C: Platinum sensitive
    Patients without any of the above HR-gene alterations included in Cohort A and B who have platinum-sensitivity, which is defined as a partial response (PR) or complete response (CR) for the best overall response (BOR) during at least 4 months on platinumbased therapy. Variants of unknown significance of candidate HR-genes from Cohort A or B will be eligible for Cohort C if they meet the partial response to platinum criterion.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 6 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Monmouth (All protocol activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (All protocol activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Basking Ridge (All protocol activities)New YorkNew York10065-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Nassau (All protocol activities)Rockville CentreNew York11553-

Find similar trials in Middletown, NJ

By research site
Memorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (All protocol activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Basking Ridge (All protocol activities)· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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