Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

NCT03245541 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 20-228
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to find out if combining durvalumab with standard stereotactic ablative radiotherapy (SABR) is an effective treatment for people with locally advanced or borderline resectable pancreatic cancer. The researchers will also look at the safety of the combination treatment and any side effects it causes.

Conditions

Pancreatic Adenocarcinoma

Keywords

Stereotactic Ablative Body Radiotherapy (SABR); Durvalumab; 20-228

Outcome Measures

Primary Outcomes (4)

• Number of participants with dose limiting toxicities in the first 10 weeks of treatment

  10 weeks

• Progression Free Survival

  Duration of time from diagnosis to time of progression

  12 months

• Proportion of participants who have resectable disease

  Based on overall downstaging of disease post-treatment

  24 weeks

• Progression Free Survival (Phase II)

  From study enrollment to time of progression

  6 months

Secondary Outcomes (4)

• Mean change in levels of inflammatory cytokines from baseline

  10 weeks

• Mean change in levels of immune cells from baseline

  10 weeks

• Mean change in protein levels from baseline

  10 weeks

• Mean change in microbiome from baseline

  10 weeks

Study Arms (1)

Durvalumab + SABR

EXPERIMENTAL

Durvalumab + Stereotactic Ablative Body Radiotherapy

Drug: Durvalumab; Radiation: Stereotactic Ablative Body Radiotherapy (SABR)

Interventions

Durvalumab DRUG

Durvalumab will be given 750 mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q14 days beginning D1. Four doses of durvalumab will be administered on the Q14 day schedule. Subsequently Durvalumab will continue as maintenance 1500mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q28 days up to 1 year or until progression (11 doses), unacceptable toxicity or other reason. If a patient undergoes resection, they will resume durvalumab once appropriately healed from surgery (approximately 4-8 weeks) at discretion of treating medical oncologist.

Also known as: Medi 4736

Durvalumab + SABR

Stereotactic Ablative Body Radiotherapy (SABR) RADIATION

SABR delivered as 6.6 Gy/fraction x 5 fractions given within two weeks will be administered weekdays and will begin D8.

Durvalumab + SABR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histopathologic or cytologic diagnosis of adenocarcinoma of the pancreas (PDAC), or suspicious for malignancy per pathology, which is deemed BR or LA PDAC per NCCN guidelines or following evaluation by a Multidisciplinary group of physicians.
• Patients must have received FOLFIRINOX for 3-6 months prior to enrollment with at least stable disease by restaging imaging.
• Note: SOC treatment regimen derived from FOLFIRINOX dose modifications are acceptable.
• To maximize potential efficacy no more than a 6-week treatment break is recommended between the completion of SOC chemotherapy (FOLFIRINOX) and initiation of study treatment (durvalumab).
• Age ≥ 18 years
• Body weight \>30kg
• ECOG 0-2
• Patients must have normal organ and marrow function as defined below:
• Absolute Neutrophil Count (ANC) ≥1.0 K/mcL
• Platelets ≥75 K/mcL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
• AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN
• Creatinine OR creatinine clearance ≤ 1.5 times the upper limit of normal OR \> 40 mL/min for patients with creatinine levels above normal.
• Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of durvalumab administration or evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).

You may not qualify if:

• History of another primary malignancy except for:
• °Malignancy treated with curative intent with no known active disease for 2 years before the first dose of study drug and low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Patients who have had prior anti-cancer treatment or are currently receiving anti-cancer treatment for their disease other than chemotherapy as stipulated by protocol.
• Women who are breastfeeding.
• Patients with Grade ≥ 2 neuropathy will be included at the investigator's discretion
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the nvestigator's discretion
• Patients who are currently receiving any other investigational agents for therapeutic treatment of their primary cancer.
• Any previous treatment with a PD1 or PD-L1 inhibitor, including Durvalumab or other immunotherapy.
• Known metastatic disease.
• Major surgical procedures based on clinical judgement of the investigator within 30 days prior to the first dose of study drug. Patients may undergo staging laparoscopy, PTC placement, ERCP, etc. at any time which should not interfere with study treatment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who are receiving radiation treatment outside of the enrolling centers.
• Patients with frank transmural macroscopic invasion of duodenum by tumor as determined by treating investigator.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• AstraZeneca: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

durvalumab

Study Officials

• Eileen O'Reilly, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: August 14, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7)