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Advanced/Metastatic Solid TumorsPhase 1NCT02444793

A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

A Phase 1 study testing PF-05082566 and KW-0761 in people with Advanced/Metastatic Solid Tumors, run by Pfizer at 21 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
PF-05082566 and KW-0761
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
21 sitesUnited States
Study dates
May 2015to Oct 2017
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.
  • Measurable disease by RECIST version 1.1.
  • For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).
  • Age 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate bone marrow, renal and liver function.
  • Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
  • Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.

Who cannot join

  • Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
  • Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
  • Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.
  • Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration.
  • Live vaccine within 30 days prior to registration.
  • Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation.
  • History of autoimmune disease or known inflammatory bowel disease.
  • Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval >470 msec.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • UNC Cancer Hospital Infusion Pharmacy

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals, University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7600

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital Research Pharmacy

    Detroit, Michigan, 48202

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037-0845

  • UC San Diego Medical Center - La Jolla(Thornton Hospital)

    La Jolla, California, 92037

  • University Of California / San Diego Moores Cancer Center

    La Jolla, California, 92093

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

  • Sanford Research

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57105

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS

This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.

Being tested
PF-05082566, KW-0761

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-05082566Drug

    Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.

  • KW-0761Drug

    Also called KW-0761= Mogamulizumab or POTELIGEO®

    Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.

Study groups in NCT02444793
Study groupRoleWhat they receive
PF-05082566 + KW-0761ExperimentalDuring Parts 1 \& 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.
Receives: Drug: PF-05082566; Drug: KW-0761

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities (DLT)

    DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting >7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade >=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade >=3 laboratory abnormalities (other than aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.

    Measured: First 2 Cycles (28 days in each cycle)

Secondary outcomes (31)

  1. Number of Participants With Treatment-Emergent Adverse Events (All Causalities)

    An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

    Measured: Day 1 up to 60 days after last dose of study treatment

  2. Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)

    An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

    Measured: Day 1 up to 60 days after last dose of study treatment

  3. Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)

    An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

    Measured: Day 1 up tp 60 days after last dose of study treatment

  4. Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4

    The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.

    Measured: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

  5. Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4

    The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).

    Measured: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

  6. Number of Participants With Clinical Significant Observations in Vital Signs

    Blood pressure (BP) and pulse rate were recorded in supine or sitting position.

    Measured: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

  7. Number of Participants With Significant Changes From Baseline in Physical Examination

    Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.

    Measured: Cycle 2 Day 1; End of the treatment.

  8. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5

    ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.

    Measured: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

  9. Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5

    Maximum Observed Serum Concentration (Cmax) was observed directly from the data.

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  10. Dose Normalized Cmax of PF-05082566-Cycle 5

    Dose normalized Cmax was calculated by Cmax / Dose

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  11. Cmax of Mogamulizumab-Cycles 1 and 5

    Maximum Observed Serum Concentration (Cmax) was observed directly from the data.

    Measured: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  12. Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5

    Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  13. Ctrough of Mogamulizumab- Cycle 5

    Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.

    Measured: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  14. Time for Cmax (Tmax) of PF-05082566-Cycle 5

    Time for Cmax (Tmax) was observed directly from the data.

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  15. Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5

    Time of last measurable concentration was observed directly from data.

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  16. Tmax of Mogamulizumab-Cycles 1 and 5

    Time for Cmax (Tmax) was observed directly from the data.

    Measured: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  17. Tlast of Mogamulizumab-Cycles 1 and 5

    Time of last measurable concentration was observed directly from the data.

    Measured: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  18. Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5

    AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  19. Dose Normalized AUClast of PF-05082566-Cycle 5

    Dose normalized AUClast was calculated by AUClast / Dose

    Measured: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

  20. AUClast of Mogamulizumab-Cycles 1 and 5

    AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.

    Measured: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  21. Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1

    AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.

    Measured: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22

  22. Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5

    AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours

    Measured: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  23. Clearance (CL) of Mogamulizumab-Cycle 5

    Clearance (CL) was measured by Dose / AUCtau

    Measured: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

  24. Anti-Drug Antibody (ADA) Titer for PF-05082566

    Serum samples were assayed for ADA using a validated analytical method.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

  25. Neutralizing Antibodies (NAb) Titers for PF-05082566

    ADA positive samples were further analyzed for NAb using a validated assay.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

  26. Anti-Drug Antibody (ADA) Titers for Mogamulizumab

    Serum samples were assayed for ADA using a validated analytical method.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

  27. Neutralizing Antibodies (NAb) Titers for Mogamulizumab

    ADA positive samples were further analyzed for NAb using a validated assay

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

  28. Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)

    OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

    Measured: Every 8 weeks up to 24 months

  29. Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion

    TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

    Measured: Every 8 weeks up to 24 months

  30. Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion

    DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.

    Measured: Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months

  31. Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion

    PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.

    Measured: Every 8 weeks up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionSep 2017
  4. Study completionOct 2017

Why it stopped: The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02444793
Sponsor's protocol ID
B1641004
Status last verified
Feb 2019
First submitted
12 May 2015
Last updated
27 Feb 2019
Data monitoring committee
No
Individual data sharing
No: 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.

Publications

  • Cohen EEW, Pishvaian MJ, Shepard DR, Wang D, Weiss J, Johnson ML, Chung CH, Chen Y, Huang B, Davis CB, Toffalorio F, Thall A, Powell SF. A phase Ib study of utomilumab (PF-05082566) in combination with mogamulizumab in patients with advanced solid tumors. J Immunother Cancer. 2019 Dec 4;7(1):342. doi: 10.1186/s40425-019-0815-6.

    PubMed 31801624

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-05082566 and KW-0761 in people with Advanced/Metastatic Solid Tumors, run by Pfizer at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLT) (time frame: First 2 Cycles (28 days in each cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02444793, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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