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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04152018




Registration number
NCT04152018
Ethics application status
Date submitted
30/10/2019
Date registered
5/11/2019

Titles & IDs
Public title
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Scientific title
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Secondary ID [1] 0 0
2020-004009-29
Secondary ID [2] 0 0
C3891001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Renal Cell Carcinoma 0 0
Ovarian Cancer 0 0
Gastric Cancer 0 0
Esophageal Cancer 0 0
Lung Squamous Cell Carcinoma 0 0
Pancreatic Cancer 0 0
Bile Duct Cancer 0 0
Endometrial Cancer 0 0
Melanoma Cancer 0 0
Urothelial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06940434
Treatment: Drugs - PF-06801591

Experimental: Dose Escalation - Single Agent Dose Escalation

Experimental: Dose Finding Anti-PD-1 Combination 1 - Part 1B PF-06940434 plus anti-PD-1

Experimental: Dose Expansion Arm A - PF-06940434 with anti-PD-1 in SCCHN

Experimental: Dose Expansion Arm B - PF-06940434 with anti-PD-1 in RCC

Experimental: Dose Expansion, Arm C - PF-06940434 with anti-PD-1 (both Q3W)


Treatment: Drugs: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated

Treatment: Drugs: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Timepoint [1] 0 0
Baseline up to 28 Days (Cycle 1)
Primary outcome [2] 0 0
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Timepoint [2] 0 0
Baseline up to approximately 24 months
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) According to Severity
Timepoint [3] 0 0
Baseline up to approximately 24 months
Primary outcome [4] 0 0
Number of Participants With Adverse Events (AEs) According to Seriousness
Timepoint [4] 0 0
Baseline up to up to approximately 24 months
Primary outcome [5] 0 0
Number of Participants With Adverse Events (AEs) by Relationship
Timepoint [5] 0 0
Baseline up to approximately 24 months
Primary outcome [6] 0 0
Progression-Free Survival (PFS) for Dose Expansion
Timepoint [6] 0 0
Baseline up to 24 Months
Primary outcome [7] 0 0
Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
Timepoint [7] 0 0
Baseline up to 24 months
Primary outcome [8] 0 0
Duration of Response (DR) for Dose Expansion
Timepoint [8] 0 0
Baseline up to 24 Months
Secondary outcome [1] 0 0
PF-06940434 after multiple doses PK parameters (Cmax).
Timepoint [1] 0 0
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [2] 0 0
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Timepoint [2] 0 0
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [3] 0 0
Systemic Clearance (CL)
Timepoint [3] 0 0
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [4] 0 0
Volume of Distribution (Vd)
Timepoint [4] 0 0
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [5] 0 0
Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.
Timepoint [5] 0 0
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [6] 0 0
Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.
Timepoint [6] 0 0
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Secondary outcome [7] 0 0
PK parameters of PF-06940434 and PF-06801591 (Cmax).
Timepoint [7] 0 0
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Secondary outcome [8] 0 0
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Timepoint [8] 0 0
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Secondary outcome [9] 0 0
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
Timepoint [9] 0 0
Cycle 4 Day 1 (each cycle is 28 days)
Secondary outcome [10] 0 0
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Timepoint [10] 0 0
Cycle 4 Day 1 (each cycle is 28 days)
Secondary outcome [11] 0 0
Number of participants with increased T-cells after PF-06940434 treatment.
Timepoint [11] 0 0
Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Secondary outcome [12] 0 0
Progression-Free Survival (PFS) for Dose Expansion
Timepoint [12] 0 0
Baseline to measured progression (up to approximately 24 months)
Secondary outcome [13] 0 0
Duration of Response (DR)
Timepoint [13] 0 0
Baseline up to approximately 24 Months
Secondary outcome [14] 0 0
Number of Participants With Objective Response for Dose Expansion portion
Timepoint [14] 0 0
Baseline up to 24 months
Secondary outcome [15] 0 0
Disease Control Rate (DCR)
Timepoint [15] 0 0
Every 8 weeks from the time of enrollment up to 2 years
Secondary outcome [16] 0 0
Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion
Timepoint [16] 0 0
Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days)
Secondary outcome [17] 0 0
Plasma Decay Half-Life (t1/2)
Timepoint [17] 0 0
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]
Secondary outcome [18] 0 0
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion
Timepoint [18] 0 0
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Secondary outcome [19] 0 0
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.
Timepoint [19] 0 0
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Secondary outcome [20] 0 0
Overall Survival
Timepoint [20] 0 0
From baseline to up to 2 years after last dose of study drug

Eligibility
Key inclusion criteria
- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.

Part 2:

* Arm A SCCHN:

* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
* PDL-1 expression positive and CPS =1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
* Arm B RCC (clear cell):

* 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
* Adequate bone marrow, kidney and liver function.
* Performance status of 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant disease status is suitable for local therapy administered with curative intent.
* Hypertension that cannot be controlled by medications.
* Active or prior autoimmune disease
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/12/2024
Actual
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul-teukbyeolsi [seoul]
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Slovakia
State/province [11] 0 0
Bratislava
Country [12] 0 0
Slovakia
State/province [12] 0 0
Komárno
Country [13] 0 0
Slovakia
State/province [13] 0 0
Poprad
Country [14] 0 0
Taiwan
State/province [14] 0 0
Tainan
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04152018