MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

Conditions

• Carcinoma
• Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 101 Years

Healthy Volunteers

Not accepted

Interventions

• Oleclumab — DRUG
  Participants will receive IV infusion of oleclumab as stated in arm description.
• Durvalumab — DRUG
  Participants will receive IV infusion of durvalumab as stated in arm description.
• Gemcitabine — DRUG
  Participants will receive IV infusion of gemcitabine as stated in arm description.
• Nab-paclitaxel — DRUG
  Participants will receive IV infusion of nab-paclitaxel as stated in arm description.
• Oxaliplatin — DRUG
  Participants will receive IV infusion of oxaliplatin as stated in arm description.
• Folinic acid — DRUG
  Participants will receive IV infusion of folinic acid as stated in arm description.
• 5-FU — DRUG
  Participants will receive IV infusion of 5-FU as stated in arm description.

Study Details

The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer.

Key Dates

Start date

Jun 21, 2018

Status verified

Sep 2023

Primary completion

Jul 22, 2022

Completion

Jul 22, 2022

Study Design

Enrollment

213 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel
  Participants with 1L metastatic disease will receive intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Experimental: Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel
  Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Experimental: Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX
  Participants with 2L metastatic disease will receive IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\^2 IV; folinic acid 400 mg/m\^2 IV; 5-FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Experimental: Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX
  Participants with 2L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\^2 IV; folinic acid 400 mg/m\^2 IV; 5-FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Active Comparator: Dose-expansion, Gemcitabine + nab-paclitaxel
  Participants with 1L metastatic disease will receive IV infusions of chemotherapy of gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Experimental: Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel
  Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
• Experimental: Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel
  Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase [ Time Frame: Day 1 through 65.7 weeks (maximum observed duration) ]

Locations (18)

Find similar trials in La Jolla, CA

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