You are here

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Last updated on December 3, 2019

FOR MORE INFORMATION
Study Location
Alaska Clinical Research Center
Anchorage, Alaska, 99503 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Carcinoma of the Head and Neck (SCCHN), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Participants must be ≥ 18 years old.

- Participants with SCCHN or mCRCP.

- Participants must have histological diagnosis of solid tumors and provide tumor
tissue.

- Measurable disease by RECIST v1.1 with at least 1 measurable lesion.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

- Adequate bone marrow, renal and liver function

- Highly effective contraceptive use by men with the ability to father a child or women
of childbearing potential.

- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as
required by local regulations) at C1D1.

- Signed and dated informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known prior severe hypersensitivity to investigational products or any component in
their formulations, including known severe hypersensitivity reactions to monocolonal
antibodies.

- Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or
pulmonary fibrosis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Prior organ transplantation including allogenic stem cell transplantation.

- Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for
administration of inactivated vaccines.

- Known symptomatic brain lesions requiring steroids.

- Known history of testing positive for human immunodeficiency virus (HIV or known
acquired immunodeficiency syndrome (AIDS).

- Positive HBV surface antigen or HCV test indicating acute or chronic infection..

- Active infection requiring systemic therapy

- Clinically significant (i.e., active) cardiovascular disease including the following:
documented left ventricular ejection fraction (LVEF) vascular accident/stroke; myocardial infarction; unstable angina; congestive heart
failure or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring
medication.

- Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately
treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast,
bladder or of the cervix and for Combination A only, low-grade (Gleason 6 or below)
prostate cancer on surveillance with no plans for treatment intervention (e.g.,
surgery, radiation, or castration) or adequately treated prostate cancer.

- Current use of immunosuppressive medication at the time of study enrollment.

- Major surgery within 4 weeks prior to study enrollment.

- Conditions that may impair intake or absorption such as inability to swallow capsules
or tablets; known malabsorption syndrome; or baseline diarrhea ? Grade 1.

- Participation in other studies involving investigational drug(s) within 2 weeks prior
to C1D1.

NCT04052204
Cheladv74
Not yet recruiting
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Cheladv74 Clinical Trial Contact Center Representative

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Descriptive Information
Brief Title  ICMJE Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination With Bempegaldesleukin(NKTR-214) With or Without Talazoparib or Enzalutamide in Participants With Locally Advanced or Metastatic Solid Tumors
Brief SummaryEvaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC).
Detailed Description

Phase 1b/ Phase 2 Design

Phase 1b will be the sequential dose-finding study.

Once the Phase 1b component is completed, Phase 2 will be initiated to further evaluate the safety and anti-tumor activity across combinations of therapy.

Combination A will enroll participants with SCCHN.

Combination B and C will enroll participants with mCRPC

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Combination A: Avelumab + Bempegaldesleukin (NKTR-214) for treatment of locally recurrent (not amendable for treatment with curative intent) or metastatic squamous cell carcinoma of the head and neck

Combination B: Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will enroll participants with DDR defect positive mCRPC.

Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC

Masking: None (Open Label)
Primary Purpose: Treatment

Condition  ICMJE
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Metastatic Castration Resistant Prostate Cancer (mCRPC)
Intervention  ICMJE
  • Drug: avelumab
    Investigational fully human anti-PD-L1 monoclonal antibody
    Other Names:
    • Bavencio
    • MSB0010718C
  • Drug: Bempegaldesleukin
    Investigational CD122-biased cytokine agonist
    Other Name: NKTR-214
  • Drug: talazoparib
    poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
    Other Name: Talzenna
  • Drug: enzalutamide
    androgen receptor inhibitor
    Other Name: Xtandi
Study Arms  ICMJE
  • Experimental: Combination A
    Avelumab + Bempegaldesleukin (NKTR-214) for treatment of locally recurrent (not amendable for treatment with curative intent) or metastatic squamous cell carcinoma of the head and neck
    Interventions:
    • Drug: avelumab
    • Drug: Bempegaldesleukin
  • Experimental: Combination B
    Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will focus on enrolling participants with DDR defect positive mCRPC.
    Interventions:
    • Drug: avelumab
    • Drug: Bempegaldesleukin
    • Drug: talazoparib
  • Experimental: Combination C
    Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC
    Interventions:
    • Drug: avelumab
    • Drug: Bempegaldesleukin
    • Drug: enzalutamide
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
170
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)
120
Estimated Study Completion Date  ICMJE October 9, 2023
Estimated Primary Completion DateOctober 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be ? 18 years old.
  • Participants with SCCHN or mCRCP.
  • Participants must have histological diagnosis of solid tumors and provide tumor tissue.
  • Measurable disease by RECIST v1.1 with at least 1 measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
  • Adequate bone marrow, renal and liver function
  • Highly effective contraceptive use by men with the ability to father a child or women of childbearing potential.
  • A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) at C1D1.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monocolonal antibodies.
  • Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Prior organ transplantation including allogenic stem cell transplantation.
  • Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for administration of inactivated vaccines.
  • Known symptomatic brain lesions requiring steroids.
  • Known history of testing positive for human immunodeficiency virus (HIV or known acquired immunodeficiency syndrome (AIDS).
  • Positive HBV surface antigen or HCV test indicating acute or chronic infection..
  • Active infection requiring systemic therapy
  • Clinically significant (i.e., active) cardiovascular disease including the following: documented left ventricular ejection fraction (LVEF) <50% by ECHO/MUGA; cerebral vascular accident/stroke; myocardial infarction; unstable angina; congestive heart failure or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring medication.
  • Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix and for Combination A only, low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration) or adequately treated prostate cancer.
  • Current use of immunosuppressive medication at the time of study enrollment.
  • Major surgery within 4 weeks prior to study enrollment.
  • Conditions that may impair intake or absorption such as inability to swallow capsules or tablets; known malabsorption syndrome; or baseline diarrhea ? Grade 1.
  • Participation in other studies involving investigational drug(s) within 2 weeks prior to C1D1.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheladv74 CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04052204
Other Study ID Numbers  ICMJE B9991040
2019-001358-24 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Cheladv74 will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Cheladv74's data sharing criteria and process for requesting access can be found at: http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da....
URL:http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da...
Responsible PartyCheladv74
Study Sponsor  ICMJE Cheladv74
Collaborators  ICMJE
  • EMD Serono
  • Nektar Therapeutics
  • Astellas Pharma Inc
Investigators  ICMJE
Study Director:Cheladv74 CT.gov Call CenterCheladv74
PRS AccountCheladv74
Verification DateNovember 2019

ICMJE     Data element required by the
and the

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now