- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094286
Durvalumab in Solid Tumors
A PHASE II EXPLORATORY STUDY OF DURVALUMAB (MEDI4736) IN HIV-1 PATIENTS WITH ADVANCED SOLID TUMORS
Study Overview
Detailed Description
PD-1/ PD-L1 coinhibitory pathway plays a significant role in the regulation of the immune response in both chronic infectious diseases and cancer.
Preclinical and animal data support the safety and promising activity of anti-PD-1 antibody in HIV-1 infection.
Demonstrated anticancer activity and safety profile of durvalumab (MEDI4736) in cancer clinical trials.
Unlikely drug interactions of durvalumab (MEDI4736) and antiretroviral treatments.
The proposal is a phase II clinical study designed to assess the feasibility of durvalumab (MEDI4736) in HIV-1-infected individuals with solid tumors. Additionally, to obtain data that lets understand the possible benefit of this treatment in cancer patients and HIV infection, exploring if activity of durvalumab (MEDI4736) could be higher in cancer that has been produced at least in part due to the chronic immunosupression. Simultaneously, it will allow us to investigate the effect of disrupting this immunoregulatory pathway might have in reversing cancer pathways and HIV-specific T-cell function during persistent chronic HIV infection in humans.
In this regard, our hypothesis is:
HIV patients with cancer have a similar outcome in terms of tolerability when treated with durvalumab (MEDI4736) monotherapy at the recommended dose than non HIV infected patients.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08036
- H. Universitario Quirón Dexeus
-
Barcelona, Spain, 08036
- H. Clínic i Provincial de Barcelona
-
Madrid, Spain, 28222
- Hospital Puerta de Hierro
-
Madrid, Spain
- H. La Paz
-
Sevilla, Spain, 41013
- Hospital Virgen del Rocío
-
Valencia, Spain
- Hospital la Fe
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- ICO-Badalona
-
Terrassa, Barcelona, Spain, 08220
- Consorci Sanitari de Terrassa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy of > 16 weeks
- Adequate normal organ and marrow function.
- Female subjects must either be of non-reproductive potential
- Subject is willing and able to comply with the protocol
- Subjects with histologically or cytologically advanced/metatasic-documented lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastrio-esophageal cancer, triple negative breast cancer, bladder or renal cancer, Cholangiocarcinoma, Kaposi sarcoma, lymphomas, ovarian cancer or Merkel cell carcinoma or any other tumor type in which anti PD-L1 antibodies have desmonstrated antitumoral activity, refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists or who refuse the standard treatment.
- Subjects may be included irrespectively of number of previous lines of treatment for advanced disease.
- Prior palliative radiotherapy must have been completed at least 2 weeks prior to start the study treatment (subjects may receive localized palliative radiotherapy while receiving study drug).
- Documented HIV-1 infection.
- Undetectable viral load in the last analysis.
- Subjects with brain metastases are eligible if they are asymptomatic, are treated or are neurological stable for at least 2 weeks without the use of steroids or on stable or decreasing dose of<10mb daily prednisone or equivalent.
- Subjects must be following an antiretroviral therapy at the moment of the inclusion.
Exclusion Criteria:
- Involvement in the planning and/or conduct of the study. Previous enrollment in the present study.
- Participation in another clinical study within last 4 weeks.
- Other untreated coexisting HIV related malignancies.
- Any previous treatment with a PD1, PD-L1 or PD-L2 inhibitor, including durvalumab.
- Receipt of the last dose of anti-cancer therapy within 28 days prior to the first dose of study drug.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab,
- Any unresolved toxicity (CTCAE grade 2) from previous anti-cancer therapy.
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
- Active or prior documented autoimmune disease within the past 2 years
- Any syndrome that requires systemic corticosteroid/immunosuppressive medications
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- History of hypersensitivity to durvalumab or any excipient.
- Uncontrolled intercurrent illness
- Known history of active tuberculosis.
- Any serious or uncontrolled medical disorder or active infection non HIV, that would impair the ability of the subject to receive the treatment of protocol therapy under treating physician criteria.
- Subjects with previous malignances, are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
- Female subjects who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an effective method of birth control.
- Symptomatic or uncontrolled brain metastases
- Subjects with uncontrolled seizures.
- Patients with tumoral disease in the head and neck region, such as peritracheal or periesophageal lymph node involvement,
- Patients with neuroendocrine tumors of pulmonary origin or pulmonary metastases with evidence of active bleeding
- Patients with digestive bleeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
|
Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of HIV patient that receive durvalumab at least during 4 months
Time Frame: From the first dose until progression disease (at 1 year approximately)
|
To explore the feasibility of durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg in solid tumors in HIV-1-infected patients
|
From the first dose until progression disease (at 1 year approximately)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess Overall Response Rate (ORR) (RECIST 1.1 and irRECIST)
Time Frame: From the first dose until the first response evaluation (8 weeks from the first dose)
|
ORR according to RECIST criteria
|
From the first dose until the first response evaluation (8 weeks from the first dose)
|
To evaluate the Progression Free Survival (PFS) rate
Time Frame: From the first dose until the first response evaluation (8 weeks from the first dose)
|
To evaluate progression free survival rate of all the patients included
|
From the first dose until the first response evaluation (8 weeks from the first dose)
|
To evaluate the Overall Survival (OS) rate
Time Frame: At month 12th from the first dose of Durvalumab
|
To evaluate overall survival rate of all the patients included
|
At month 12th from the first dose of Durvalumab
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: María González-Cao, MD, Instituto Oncológico Dr Rosell
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GECP 16/04_DURVAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Durvalumab
-
AstraZenecaKappa SantéRecruiting
-
Yonsei UniversityRecruitingPotentially Resectable Stage II/IIIa NSCLCKorea, Republic of
-
Academic Thoracic Oncology Medical Investigators...AstraZenecaCompletedNon-Small Cell Lung Cancer NSCLCUnited States
-
Yonsei UniversityCompleted
-
NSABP Foundation IncCompletedRectal CancerUnited States
-
Hark Kyun KimRecruiting
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
MedImmune LLCCompletedAdvanced Solid TumorsUnited States, France, Spain, Switzerland
-
Yonsei UniversityNot yet recruitingNon Small Cell Lung CancerKorea, Republic of
-
AstraZenecaCompleted