Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Harry H Yoon
Study ID
NCT04069273
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab Monotherapy — DRUG
    Pembrolizumab 200 mg IV
  • Ramucirumab — DRUG
    Ramucirumab 10 mg/kg IV
  • Paclitaxel — DRUG
    Paclitaxel 90 mg/m2 IV

Study Details

Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.

Key Dates

Start date
Dec 1, 2020
Status verified
Jul 2025
Primary completion
Jun 11, 2026
Completion
Dec 10, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Pembrolizumab will be administered every 3 weeks in combination with ramucirumab + paclitaxel. The paclitaxel schedule differs between the 2 arms.
  • Experimental: Arm B
    Pembrolizumab will be administered every 3 weeks in combination with ramucirumab + paclitaxel. The paclitaxel schedule differs between the 2 arms.

Primary Outcome Measure

Cohort 1: Evaluate the best overall response rate (BORR) by pooling Arm A and Arm B [ Time Frame: 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic- MinnesotaRochesterMinnesota55905
Wendy Ferguson
[email protected]
5075381665
Harry Yoon, MD (PRINCIPAL_INVESTIGATOR)
Froedtert and The Medical College of WisconsinMilwaukeeWisconsin53226
Stacey Zindars, MS
[email protected]
414-805-8913
Ben George, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

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By specialty
OncologyGI oncology
By research site
Mayo Clinic- Minnesota· Rochester, MNFroedtert and The Medical College of Wisconsin· Milwaukee, WI

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