NCT04052204

Brief Summary

Evaluation 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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2019

Geographic Reach
4 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 14, 2021

Completed
Last Updated

October 14, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

August 2, 2019

Results QC Date

August 2, 2021

Last Update Submit

September 17, 2021

Conditions

Squamous Cell Carcinoma of the Head and Neck (SCCHN)Metastatic Castration Resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Dose Limiting Toxicities (DLT)

    DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category.

    Cycle 1 of the treatment period (28 days)

Secondary Outcomes (10)

  • Duration of Response (DR)

    Approximately 8 months (246 days).

  • Time to Tumor Response (TTR)

    Approximately 8 months (246 days).

  • Progression-Free Survival (PFS)

    Approximately 8 months (246 days).

  • Overall Survival (OS)

    Approximately 8 months (246 days).

  • Pharmacokinetic (PK) Parameters - Cmax and Ctrough for Avelumab and NKTR-214

    Blood samples were collected on Day 1 and Day 15 in Cycle 1 and Cycle 2 for avelumab. Blood samples were collected on Day 1, Day 3, Day 4 and Day 8 in Cycle 1, Day1 and Day 8 in Cycle 2 for NKTR-214.

  • +5 more secondary outcomes

Study Arms (3)

Combination A

EXPERIMENTAL

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

Drug: avelumabDrug: Bempegaldesleukin

Combination B

EXPERIMENTAL

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.

Drug: avelumabDrug: BempegaldesleukinDrug: talazoparib

Combination C

EXPERIMENTAL

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

Drug: avelumabDrug: BempegaldesleukinDrug: enzalutamide

Interventions

avelumabDRUG

Investigational fully human anti-PD-L1 monoclonal antibody

Also known as: Bavencio, MSB0010718C
Combination ACombination BCombination C
BempegaldesleukinDRUG

Investigational CD122-biased cytokine agonist

Also known as: NKTR-214
Combination ACombination BCombination C
talazoparibDRUG

poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor

Also known as: Talzenna
Combination B
enzalutamideDRUG

androgen receptor inhibitor

Also known as: Xtandi
Combination C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 or transient ischemic attack; 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

GZA Ziekenhuizen campus Sint-Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Hospital Quirón Barceloma

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

avelumabbempegaldesleukintalazoparibenzalutamide

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Limitations and Caveats

Phase 1b part of Combination A was conducted but not completed as company terminated this study on 21 May 2021. Termination was not due to a regulatory request or new emerging safety signals. Test for Combination B, Combination C and Phase 2 expansion for Combination A planned in the protocol were not conducted.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials_gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 9, 2019

Study Start

December 30, 2019

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

October 14, 2021

Results First Posted

October 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Pfizer 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 Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

US(1)PL(1)ES(2)BE(1)