Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens
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ClinicalTrials.gov Identifier: NCT02537418 |
Recruitment Status :
Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : February 12, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 27, 2015 | ||||||
First Posted Date ICMJE | September 1, 2015 | ||||||
Last Update Posted Date | February 12, 2024 | ||||||
Actual Study Start Date ICMJE | October 16, 2015 | ||||||
Actual Primary Completion Date | July 20, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy [ Time Frame: 24 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens | ||||||
Official Title ICMJE | A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens | ||||||
Brief Summary | The purpose of this study is to find the highest dose of durvalumab or of durvalumab with tremelimumab that can be tolerated without causing very severe side effects when receiving standard chemotherapy and to see what effects the study drugs has on this type of cancer. Patients may receive durvalumab alone or in combination with tremelimumab. | ||||||
Detailed Description | The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by the study drugs, durvalumab and tremelimumab. This is done by starting at a dose lower than the one that does not cause side effects in animals. Participants are given durvalumab alone or durvalumab together with tremelimumab and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of durvalumab together with tremelimumab. Participants joining this study later on will get higher doses of durvalumab together with tremelimumab than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The second purpose is to see if there are any differences in the side effects and the way durvalumab and tremelimumab are handled in your body when durvalumab is given together at the same time with tremelimumab compared to when durvalumab is given after tremelimumab. This is called dose level five. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Solid Malignancies | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: durvalumab ± tremelimumab
durvalumab; Day 1 every 3 weeks or 4 weeks tremelimumab; every 3-6 weeks for a total of 1-6 doses Interventions:
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Publications * | Juergens RA, Hao D, Ellis PM, Tu D, Mates M, Kollmannsberger C, Bradbury PA, Tehfe M, Wheatley-Price P, Robinson A, Bebb G, Laskin J, Goffin J, Hilton J, Tomiak A, Hotte S, Goss GD, Brown-Walker P, Sun X, Tsao MS, Cabanero M, Gauthier I, Song X, Dennis PA, Seymour LK, Smoragiewicz M, Laurie SA. A phase IB study of durvalumab with or without tremelimumab and platinum-doublet chemotherapy in advanced solid tumours: Canadian Cancer Trials Group Study IND226. Lung Cancer. 2020 May;143:1-11. doi: 10.1016/j.lungcan.2020.02.016. Epub 2020 Feb 28. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
153 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Estimated Study Completion Date ICMJE | December 31, 2024 | ||||||
Actual Primary Completion Date | July 20, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Previous Therapy • Cytotoxic Chemotherapy: All Cohorts Except Etoposide-Carboplatin: • Patients should not have received prior chemotherapy for advanced disease. Exceptions may be made for selected patients and regimens. Patients planned for dose level 5 may have received one line or prior chemotherapy. Consult CCTG before approaching patients. Notes: Patients planned for cisplatin regimens should have received no more than 250mg mg/m2 prior to cisplatin. Etoposide-Carboplatin Cohort: • For dose levels 0-3, patients with untreated SCLC must have received two cycles of their first etoposide carboplatin regimen prior to registration to that chemotherapy cohort. For dose level 4, SCLC patients planned for the etoposide/carboplatin cohort may not have had prior chemotherapy regimens and do not have to have their first two cycles of etoposide-platinum prior to study entry. Other Systemic Therapy:
Longest of one of the following:
Radiation: • Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of registration. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. Patients planned for concurrent chemotherapy-radiation are not eligible. Patients with curative doses of radiation to marrow-bearing areas may not be eligible. Consult CCTG. Surgery: • Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred.
Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L
Bilirubin ≤ 1.5 x ULN (upper limit of normal) * If confirmed Gilbert's, eligible providing ≤ 3 x UNL; AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 x UNL) Serum creatinine < 1.25 x ULN or: Creatinine clearance ≥ 50 mL/min
Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
Exclusion Criteria:
Men and women of child-bearing potential must agree to use adequate contraception.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02537418 | ||||||
Other Study ID Numbers ICMJE | I226 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Canadian Cancer Trials Group | ||||||
Original Responsible Party | NCIC Clinical Trials Group | ||||||
Current Study Sponsor ICMJE | Canadian Cancer Trials Group | ||||||
Original Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||||
Collaborators ICMJE | AstraZeneca | ||||||
Investigators ICMJE |
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PRS Account | Canadian Cancer Trials Group | ||||||
Verification Date | August 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |