Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies

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NCT04181788

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Study Location
Medical University "REAVIZ"
Samara, Amurskaya Oblast, 443011, Russian Federation
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Malignancies, Non-small-cell Lung Cancer
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

- Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea)

- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow function, renal and liver functions Phase 1b

- Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent

- Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2

- Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC

- EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted

- Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS] ≥1%) or unknown are eligible

- Up to 1 line of prior therapy in advanced or metastatic disease settings allowed

- Participant should not have received prior treatment with anti PD-1/PD-L1 drugs

- At least one measurable lesion as defined by RECIST version 1.1

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


- Participants with known symptomatic brain metastases requiring steroids


- Participants with Interstitial Lung Disease history or complication


- Q-T interval corrected for heart rate QTc > 450 msec for male participants or QTc >
470 msec for female participants or QTc > 480 msec in participants with right bundle
branch block.


- Hypertension that cannot be controlled by medications (eg, systolic > 150 mmHg and
diastolic > 90 mmHg) despite optimal medical therapy.


- Known or suspected hypersensitivity to active ingredient or excipients of the study
drug.


- History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where
considered drug related and cytokine release syndrome [CRS]) that was considered
related to prior immune modulatory therapy (eg, immune checkpoint inhibitors,
co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b
only).


- Vaccination with live attenuated vaccines within 4 weeks prior to randomization is
prohibited; however inactivated vaccines are permitted.

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Advanced Malignancies, Non-small-cell Lung CancerSasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
NCT04181788
  1. Samara, Amurskaya Oblast
  2. Chelyabinsk, Chelyabinsk Region
  3. Chelyabinsk,
  4. Kropyvnytskyi,
  5. Chuo-ku, Tokyo
  6. Seongnam-si, Gyeonggi-do
  7. Seoul, Seoul-teukbyeolsi[seoul]
  8. Incheon,
  9. Seoul,
  10. Seoul,
  11. Saint Petersburg, Pesochny
  12. Pushkin, Saint-petersburg
  13. Pyatigorsk, Stavropol Region
  14. Yaroslavl, Yaroslavskaya Oblast'
  15. Chelyabinsk,
  16. Chelyabinsk,
  17. Kaliningrad,
  18. Kaliningrad,
  19. Kaliningrad,
  20. Orenburg,
  21. Pesochny, Saint Petersburg,
  22. Saint Petersburg,
  23. Saint Petersburg,
  24. Saint-Petersburg,
  25. Saint-Petersburg,
  26. Saint-Petersburg,
  27. Saint-Petersburg,
  28. Saint-Petersburg,
  29. Kaohsiung,
  30. Tainan,
  31. Taipei,
  32. Pliuty Village, Obuhiv District, KIEV Region
  33. Khodosivka, Kyivska Oblast
  34. Sumy, Sumska Oblast
  35. Sumy, SUMY Region
  36. Dnipro,
  37. Dnipro,
  38. Dnipro,
  39. Ivano-Frankivsk,
  40. Kyiv,
  41. Kyiv,
  42. Kyiv,
  43. Odesa,
  44. Odesa,
  45. Odesa,
  46. Uzhgorod,
  47. Uzhgorod,
  48. Zhytomyr,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
Official Title  ICMJE A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Brief Summary

This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies.

This study consists of 2 parts:

Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancies
  • Non-small-cell Lung Cancer
Intervention  ICMJE Drug: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
Study Arms  ICMJE
  • Experimental: Arm A1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm A2 (Phase 2)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B2 (Phase 2)
    Intervention: Drug: PF-06801591
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2020)		126
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)		102
Estimated Study Completion Date  ICMJE April 25, 2025
Estimated Primary Completion Date April 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ?18 years (? 20 years in Japan; ? 19 years in South Korea)
  • Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow function, renal and liver functions Phase 1b
  • Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent
  • Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2
  • Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
  • EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted
  • Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS] ?1%) or unknown are eligible
  • Up to 1 line of prior therapy in advanced or metastatic disease settings allowed
  • Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
  • At least one measurable lesion as defined by RECIST version 1.1

Exclusion Criteria:

  • Participants with known symptomatic brain metastases requiring steroids
  • Participants with Interstitial Lung Disease history or complication
  • Q-T interval corrected for heart rate QTc > 450 msec for male participants or QTc > 470 msec for female participants or QTc > 480 msec in participants with right bundle branch block.
  • Hypertension that cannot be controlled by medications (eg, systolic > 150 mmHg and diastolic > 90 mmHg) despite optimal medical therapy.
  • Known or suspected hypersensitivity to active ingredient or excipients of the study drug.
  • History of Grade ?3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome [CRS]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only).
  • Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.
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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Russian Federation,   Taiwan,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181788
Other Study ID Numbers  ICMJE B8011007
2019-003818-14 ( EudraCT Number )
Has Data Monitoring Committee No
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: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP