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Durvalumab in Solid Tumors

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ClinicalTrials.gov Identifier: NCT03094286
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Cancer Drug: Durvalumab Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous(IV) administration
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II EXPLORATORY STUDY OF DURVALUMAB (MEDI4736) IN HIV-1 PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Durvalumab
U.S. FDA Resources

Arms and Interventions

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
Drug: Durvalumab
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 Name: MEDI4736


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. Age > 18 years at time of study entry.
  3. Eastern Cooperative Oncology Group (ECOG) 0-2
  4. Life expectancy of > 16 weeks
  5. Adequate normal organ and marrow function.
  6. Female subjects must either be of non-reproductive potential
  7. Subject is willing and able to comply with the protocol
  8. Subjects with histologically or cytologically advanced/metatasic-documented lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastric cancer, triple negative breast cancer, bladder or renal cancer, refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists or who refuse the standard treatment.
  9. Subjects may be included irrespectively of number of previous lines of treatment for advanced disease.
  10. 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).
  11. Documented HIV-1 infection with a CD4 count over 350 cells/mm3
  12. Subjects with brain metastases are eligible if they are asymptomatic,

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study. Previous enrollment in the present study.
  2. Participation in another clinical study within last 4 weeks.
  3. Other untreated coexisting HIV related malignancies.
  4. Any previous treatment with a PD1, PD-L1 or PD-L2 inhibitor, including durvalumab.
  5. Receipt of the last dose of anti-cancer therapy within 28 days prior to the first dose of study drug.
  6. Mean QT interval corrected for heart rate (QTc) ≥470 ms
  7. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab,
  8. Any unresolved toxicity (CTCAE grade 2) from previous anti-cancer therapy.
  9. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
  10. Active or prior documented autoimmune disease within the past 2 years 11. Any syndrome that requires systemic corticosteroid/immunosuppressive medications

12. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).

13. History of primary immunodeficiency. 14. History of allogeneic organ transplant. 15. History of hypersensitivity to durvalumab or any excipient. 16. Uncontrolled intercurrent illness 17. Known history of active tuberculosis. 18. 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.

19. 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.

20. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.

21. Female subjects who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an effective method of birth control.

22. Symptomatic or uncontrolled brain metastases 23. Subjects with uncontrolled seizures. 24. Patients with tumoral disease in the head and neck region, such as peritracheal or periesophageal lymph node involvement, 25. Patients with neuroendocrine tumors of pulmonary origin or pulmonary metastases with evidence of active bleeding 26. Patients with digestive bleeding

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094286


Locations
Spain
ICO-Badalona Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Teresa Morán, PhD         
Contact       epereira@gecp.org   
Principal Investigator: Teresa Morán Bueno, MD-PhD         
Consorci Sanitari de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08220
Contact: Remei Blanco, MD-PhD    +34 93 430 20 06    rblanco@cst.cat   
Contact       epereira@gecp.org   
Principal Investigator: Remei Blanco, MD-PhD         
H. Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Javier García Corbacho, MD    +34 690 2 46 39    GARCIA33@clinic.cat   
Principal Investigator: Javier García Corbacho, MD         
H. Universitario Quirón Dexeus Not yet recruiting
Barcelona, Spain, 08036
Contact: Maria González Cao         
Contact       epereira@gecp.org   
Principal Investigator: Maria Gonzalez Cao, MD-PhD         
Hospital Puerta de Hierro Not yet recruiting
Madrid, Spain, 28222
Contact: Mariano Provencio         
Contact       epereira@gecp.org   
Principal Investigator: Mariano Provencio, MD         
H. La Paz Not yet recruiting
Madrid, Spain
Contact: Javier de Castro, MD         
Principal Investigator: Javier de castro, MD         
Hospital Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Reyes Bernabé, MD         
Contact       epereira@gecp.org   
Principal Investigator: Reyes Bernabé, MD         
Hospital La Fe Not yet recruiting
Valencia, Spain
Contact: Oscar Juan         
Principal Investigator: Oscar Juan         
Sponsors and Collaborators
Spanish Lung Cancer Group
More Information

Additional Information:
Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT03094286     History of Changes
Other Study ID Numbers: GECP 16/04_DURVAST
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spanish Lung Cancer Group:
HIV
HIV with cancer patient
D006678

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs