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New treatment option for Pancreatic Cancer
Official title Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
ClinicalTrials.gov ID: NCT05451043
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Also referred to as Imfinzi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single-arm, interventional study combining Immunotherapy and propranolol with/without chemotherapy and propranolol 1. Pancreatic Cancer Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1/8/15) and continuous propranolol.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be 18 years of age or older.
- Body Weight \>30kg
- Life expectancy of at least 12 weeks
- Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to...
- Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities...
You likely can't join if
- Patients who have received prior palliative systemic treatment for their advanced cancer.
- History of pneumonitis requiring treatment with steroids.
- History of active interstitial lung disease.
- For HCC patients they must have a Child Pugh status of A.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled...
See the full eligibility criteria
Who can join
- Patients must be 18 years of age or older.
- Body Weight \>30kg
- Life expectancy of at least 12 weeks
- Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery. For the histologies there must...
- Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities recovered to grade 1 or less.
- Patients must be capable of providing consent to enrolment and treatment.
- Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see Appendix 1).
- Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).
- Women of child-bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical...
- Patients (men and women) of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after...
- Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of durvalumab monotherapy or 180 days after the last does of durvalumab...
- Male patients should agree to not donate sperm during the study and for a period of at least 6 months after last dose of study drug.
- Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.
- The following adequate organ function laboratory values must be met: Hematological:
- Absolute neutrophil count (ANC) \>1.5 x109/L
- For the Hepatocellular cohort Platelet count \>/ 1.0 x109/L is adequate Platelet count \>100 x109/L
- For the Hepatocellular cohort Platelet count \>/ 65 x109/L is adequate Hemoglobin \>9 g/dL (may have been transfused) Renal:
- Estimated creatinine clearance ≥ 45 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Hepatic:
- Total serum bilirubin \<1.5x ULN o For the HCC cohort bilirubin ≤ 2 x ULN
- AST and ALT \<2.5x ULN (or ≤ 5 x ULN for patients with documented metastatic disease to the liver)
What rules you out
- Patients who have received prior palliative systemic treatment for their advanced cancer.
- History of pneumonitis requiring treatment with steroids.
- History of active interstitial lung disease.
- For HCC patients they must have a Child Pugh status of A.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \<\<for durvalumab monotherapy and durvalumab + tremelimumab combination...
- History of another malignancy or a concurrent malignancy;
- Exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical...
- Active brain metastases or leptomeningeal disease.
- Patients with treated brain metastases that have been treated, are off steroids and anticonvulsants and have imaging documenting stability of brain metastases for 6 weeks post treatment will be eligible for enrolment.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic...
- Prior organ transplantation including allogeneic stem-cell transplantation.
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive...
- Active infection requiring systemic therapy or Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with...
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5.0 Grade ≥ 3).
- Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation...
- Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 grade \> 1); however, alopecia, sensory neuropathy ≤ grade 2, or other toxicities ≤ grade 2 not constituting a safety risk based on investigator's judgment...
- Enrollment in any other clinical protocol or investigational study with an treatment agent or assessments that may interfere with study procedures.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab...
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
- Asthma requiring corticosteroid inhalers and having been admitted within the last year for an asthma exacerbation
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.