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NY-ESO-1ᶜ²⁵⁹T Alone and in Combination With Pembrolizumab for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03168438
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE August 18, 2017
Estimated Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Number of subjects with Treatment Limiting Toxicities (TLT), adverse events (AE), including serious adverse events (SAE). [ Time Frame: Up to 3.8 years ]
Adverse events (AEs), including serious adverse event (SAEs) and treatment limiting toxicities (TLTs with combination only); laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments by electrocardiogram (ECG).
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
Number of subjects with Treatment Limiting Toxicities (TLT), adverse events (AE), including serious adverse events (SAE). [ Time Frame: 3.5 years ]
Adverse events (AEs), including serious adverse event (SAEs) and treatment limiting toxicities (TLTs with combination only); laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments by electrocardiogram (ECG).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Proportion of subjects with a positive response : Partial Response (PR), Very Good Partial response (VGPR), Complete Response (CR) or stringent CR (sCR) [ Time Frame: Up to 3.8 years ]
    Evaluation of the efficacy of the treatment by assessment of the Overall Response rate (ORR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria.
  • Interval between the date of T-cell infusion and first documented evidence of positive response (PR, VGPR, CR, sCR) [ Time Frame: Up to 3.8 years ]
    Evaluation of the efficacy of the treatment by assessment of time to first response (Time to Response (TTR))
  • Interval between the date of first documented evidence of response (PR, VGPR, CR, sCR) until first documented disease progression (PD) or death due to any cause [ Time Frame: Up to 3.8 years ]
    Evaluation of the efficacy of the treatment by assessment of duration of response.
  • Interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause [ Time Frame: Up to 3.8 years ]
    Evaluation of the efficacy of the treatment by assessment of progression-free survival (PFS).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Proportion of subjects with a positive response : Partial Response (PR), Very Good Partial response (VGPR), Complete Response (CR) or stringent CR (sCR) [ Time Frame: 3.5 years ]
    Evaluation of the efficacy of the treatment by assessment of the Overall Response rate (ORR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria.
  • Interval between the date of T-cell infusion and first documented evidence of positive response (PR, VGPR, CR, sCR) [ Time Frame: 3.5 years ]
    Evaluation of the efficacy of the treatment by assessment of time to first response (Time to Response (TTR))
  • Interval between the date of first documented evidence of response (PR, VGPR, CR, sCR) until first documented disease progression (PD) or death due to any cause [ Time Frame: 5 years ]
    Evaluation of the efficacy of the treatment by assessment of duration of response.
  • Interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause [ Time Frame: 5 years ]
    Evaluation of the efficacy of the treatment by assessment of progression-free survival (PFS).
  • Interval between the date of T cell infusion and the earliest date of death due to any cause [ Time Frame: 7 years ]
    Evaluation of the efficacy of the treatment by assessment of overall survival (OS).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2017)
  • Assessment of response by correlating Minimal Residual Disease (MRD) with PFS and OS [ Time Frame: 4.5 years ]
    Molecular identification and quantification of the clonotypic sequence will be performed by Next-Gen Sequencing on bone marrow samples collected before and 100 days after T cell infusion.
  • Correlation of NY-ESO-1ᶜ²⁵⁹T persistence, phenotype and functionality with response to treatment [ Time Frame: 4.5 years ]
    Flow cytometry will be used to assess the phenotype of transduced T cells in the manufactured product and in post-infusion samples.
  • Assessment of loss of antigen expression as resistance mechanism [ Time Frame: 4.5 years ]
    Expression of NY-ESO-1, LAGE-1a and CD138 (marker of plasma cells) in bone marrow aspirates will be assessed by qRT-PCR at different time points after T cell infusion in order to assess tumor burden and antigen expression.
  • Evaluation of potential antigenicity of NY-ESO-1ᶜ²⁵⁹T cell receptor [ Time Frame: 4.5 years ]
    The presence of antibodies directed against the NY-ESO-1ᶜ²⁵⁹T cell receptor in serum ("anti-drug antibodies") will be measured by ELISA using a custom assay and will be analyzed in relation to persistence of transduced T cells in peripheral blood.
  • Evaluation of the role of expression of PD-1 and PD-L1 in bone marrow in response to treatment [ Time Frame: 4.5 years ]
    Expression of PD-1 and PD-L1 in Bone Marrow Mononuclear Cells (BMMC) isolated from BM aspirates will be measured by flow cytometry. When BM biopsies are collected, IHC will be used to assess expression of PD-L1 on plasma cells and in the microenvironment.
  • Investigation of cellular and molecular biomarkers of response in BM samples [ Time Frame: 4.5 years ]
    BM aspirates will be analyzed at the cellular level (flow cytometry) and at the molecular level (gene expression profiling) to identify markers of immune response (immune cell subsets, immune-modulatory molecules, etc.)
  • Correlation of clonal outgrowth of T-cell populations with response following T-cell infusion [ Time Frame: 4.5 years ]
    Assessment of the polyclonality status of the T cell population in peripheral blood and BM aspirates will be performed by TCR sequencing (NGS)
  • Measurement of cytokines in relation to CRS [ Time Frame: 4.5 years ]
    Cytokines will be quantified in peripheral blood and BM serum before and after T-cell infusion using a multiplex assay (e.g. Luminex)
 
Descriptive Information
Brief Title  ICMJE NY-ESO-1ᶜ²⁵⁹T Alone and in Combination With Pembrolizumab for Multiple Myeloma
Official Title  ICMJE Open-Label Randomized Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination With Pembrolizumab in HLA-A2+ Subjects With NY-ESO-1 and/or LAGE 1A Positive Relapsed and Refractory Multiple Myeloma
Brief Summary

This study is intended for men and women at least 18 years of age who have relapsed and/or refractory multiple myeloma. This 2-arm randomized pilot study will test the safety, tolerability and efficacy of NY-ESO-1ᶜ²⁵⁹T alone (Arm 1) or in combination with pembrolizumab (Arm 2) in subjects who have the appropriate HLA-A2 marker, and whose bone marrow expresses the NY-ESO-1 and/or LAGE-1a protein.

This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors.

Detailed Description

This is a randomized pilot study of the efficacy and safety of NY-ESO-1ᶜ²⁵⁹T alone or in combination with pembrolizumab in patients with relapsed or refractory multiple myeloma, who are HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 positive, and whose plasma cells from a bone marrow (BM) aspirate test positive for NY-ESO-1 and/or LAGE-1a antigen.

Subjects meeting all eligibility criteria will be randomly assigned to a treatment Arm: NY-ESO-1ᶜ²⁵⁹T alone (Arm 1) or NY-ESO-1ᶜ²⁵⁹T in combination with pembrolizumab (Arm 2).

Leukapheresis is performed to obtain cells for the manufacture of autologous NY-ESO-1ᶜ²⁵⁹T cells. When the manufactured NY-ESO-1ᶜ²⁵⁹T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by a single infusion of NY-ESO-1ᶜ²⁵⁹T (transduced cell range: 1 to 8 billion cells) that will be administered on Day 1.

In Arm 2, three (3) weeks after the infusion of NY-ESO-1ᶜ²⁵⁹T, an initial dose of pembrolizumab will be administered on Day 22. If toxicities preclude Week 3 treatment, the first dose of pembrolizumab may be given at Week 6 (Day 43). The second dose of pembrolizumab will be administered 3 weeks later, at Week 6 (or Week 9), and subsequent doses of pembrolizumab will be administered every 3 weeks thereafter up to Week 108 post T-cell infusion.

Treatment Limiting Toxicities (TLTs) will be evaluated for subjects in the combination arm (Arm 2).

A complete safety review of the first 3 subjects dosed with T-cells and pembrolizumab on Arm 2 will be conducted before enrolling any further subject. The study may be paused to evaluate safety at any time or if at an interim assessment the predictive probability that the TLT rate at the end of the trial exceeds 33%, is greater than 50%.

Efficacy will be assessed using International Myeloma Working Group (IMWG) Uniform Response Criteria.

Upon confirmation of their disease progression, subjects will be considered completing for the primary analysis. Subjects will complete the study once they have met the criteria to be transferred into a Long-Term Follow-Up protocol, where they will continue to be followed for up to 15 years from the date of their T-cell infusion.

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 Neoplasms
Intervention  ICMJE
  • Genetic: NY-ESO-1ᶜ²⁵⁹T cells
    NY-ESO-1ᶜ²⁵⁹T cells administered by infusion on Day 1
  • Drug: NY-ESO-1ᶜ²⁵⁹T in combination with pembrolizumab
    NY-ESO-1ᶜ²⁵⁹T cells administered on Day 1, then pembrolizumab administered on Day 22 (3 weeks after initial infusion of NY-ESO-1ᶜ²⁵⁹T cells)
Study Arms  ICMJE
  • Experimental: Arm 1: NY-ESO-1ᶜ²⁵⁹T cells
    Subjects will receive one infusion of NY-ESO-1ᶜ²⁵⁹T cells on Day 1.
    Intervention: Genetic: NY-ESO-1ᶜ²⁵⁹T cells
  • Experimental: Arm 2: NY-ESO-1ᶜ²⁵⁹T in combination with pembrolizumab
    NY-ESO-1ᶜ²⁵⁹T cells administered on Day 1, then pembrolizumab administered on Day 22 (3 weeks after initial infusion of NY-ESO-1ᶜ²⁵⁹T)
    Intervention: Drug: NY-ESO-1ᶜ²⁵⁹T in combination with pembrolizumab
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: May 24, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2023
Estimated Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has voluntarily agreed to participate by giving written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines and applicable local regulations.
  2. Subject has voluntarily agreed to abide by all protocol required procedures including study related assessments, and management by the treating institution for the duration of the study and long-term follow-up.
  3. Subjects must be 18 years of age or older at the date of consent.
  4. Histologically confirmed diagnosis of secretory multiple myeloma (must have measurable M protein in serum or urine) with at least one of the following: a. Serum M- protein ≥0.5 g/dL (≥5 g/L) for IgG, IgM, IgA, or ≥0.05 g/dL for IgD; or b. Urine M-protein ≥200 mg/24 hours ; or c. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  5. Subject must have documented diagnosis of either: a. primary refractory myeloma (PRMM): subjects who have never achieved the minimal response or better to prior therapy OR b. relapsed and refractory multiple myeloma (RRMM): subjects who have received at least 2 prior regimen, were responsive to at least 1 prior regimen (as defined by IMWG criteria) and then are refractory to their most recent therapy (≤ 25% response or progression during therapy or within 60 days after completion of therapy). Prior therapies for subjects with PRMM or RRMM must include an immunomodulatory drug (IMiD) and a proteasome inhibitor as separate lines or a combined line of therapy. If prior therapy includes autologous stem cell transplantation (ASCT), then the succession of induction/ASCT/maintenance therapies will be considered as one line of therapy altogether. Subjects who have relapsed after ASCT or are unable to receive ASCT are eligible. The interval from ASCT to entry in the study must be ≥12 weeks.
  6. Subject is HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 positive as determined by a central laboratory. (This determination will be made under a pre enrollment screening informed consent form [ICF]. There are no restrictions on the timing of HLA typing for screening and data can be taken from subjects' records).
  7. Subject has confirmed sufficient expression of NY-ESO-1 and/or LAGE-1a by reverse transcription polymerase chain reaction (RT-PCR) as determined by a central laboratory contracted by the Sponsor (this determination will also be made under a pre-enrollment screening ICF).
  8. Left ventricular ejection fraction (LVEF) ≥50%. A lower LVEF (≥40%) is permissible if a formal cardiologic evaluation reveals no evidence for clinically significant functional impairment, otherwise the subject may not enter the study.
  9. Subject is fit for leukapheresis and has adequate venous access for the cell collection.
  10. Subject has adequate vital organ function, as per protocol-defined laboratory values for Absolute Neutrophil count (ANC), platelets, hemoglobin, Prothrombin Time (PT) or International Normalized Ratio (INR), Partial Thromboplastin Time (PTT), measured or calculated creatinine clearance, serum total bilirubin, Aspartate aminotransferase (AST)/ Serum Glutamic Oxaloacetic Transaminase (SGOT), and Alanine aminotransferase (ALT)/ Serum Glutamic Pyruvic Transaminase (SGPT).
  11. For subjects who have received prior checkpoint inhibitors: a. Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. b. Must not have experienced any ≥ Grade 3 AE nor any neurologic or ocular AE of any grade while receiving prior checkpoint inhibitors. c. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE related to checkpoint inhibitors, not have experienced recurrence of an AE related to checkpoint inhibitors if re challenged, and not currently require maintenance doses of corticosteroids.
  12. Subject has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  13. Male or Female subjects can participate. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male subjects are eligible to participate if they agree to the following during the period starting at the first dose of chemotherapy for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the subject's blood, whichever is longer. If randomized to Arm 2 must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. Males should Refrain from donating sperm or either be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as follows: Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing (WOCBP) potential who is not currently pregnant, or agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person. Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: she is not a WOCBP OR she is a WOCBP who will agree to use a barrier method (male condom) and use a contraceptive method that is highly effective (with a failure rate of <1% per year), during the period starting at the first dose of chemotherapy, for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the subject's blood, whichever is longer. If randomized to Arm 2 must use a barrier method (male condom) and a highly effective contraception (with a failure rate of <1% per year) for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Exclusion Criteria:

  1. Subjects with only plasmacytomas, plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), nonsecretory myeloma or primarily amyloidosis.
  2. Subject has already received one of the following therapy/treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor.
  3. Subject has received or plans to receive the following excluded therapy/treatment within specified time frames prior to leukapheresis or lymphodepleting chemotherapy. Required Wash-out periods: a. Cytotoxic chemotherapy -2 weeks b. Immune therapy (including monoclonal antibody therapy) -6 weeks c. Immunomodulator therapy (IMiD e.g. lenalidomide or thalidomide) -1 week d. Proteasome inhibitor therapy (e.g. bortezomib or carfilzomib) -2 weeks e. Anticancer Vaccine -2 months NOTE: The subject should be excluded if the Investigator considers their disease is responding to an experimental vaccine given within 6 months f. Live-virus vaccination -4 weeks NOTE: Seasonal flu vaccines that do not contain live virus are not an exclusion. g. Gene therapy using an integrating vector Allogeneic hematopoietic stem cell transplant at any time not permitted h. Corticosteroids or any other immunosuppressive therapy -2 weeks NOTE: Use of inhaled or topical steroids is not an exclusion i. Investigational treatment - 4 weeks j. Radiotherapy - 2 weeks NOTE: Duration of any other anticancer therapies must be discussed with the Sponsor Study Physician
  4. Subjects who have previously participated in Merck pivotal trial NCT02576977: Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (RRMM) (MK-3475-183/KEYNOTE-183).
  5. Subject has toxicity from previous anticancer therapy that has not recovered to ≤ Grade 1 or to their baseline level of organ function prior to enrollment (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled on a case-by-case basis with prior consultation and agreement with the Sponsor Study Physician.
  6. Subject had major surgery within 4 weeks prior to randomization (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities.
  7. Subject has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
  8. Known history of myelodysplasia.
  9. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice or cirrhosis.
  10. Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
  11. Subject has an active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human T-lymphotropic virus (HTLV) as defined below: a. Positive serology for HIV. b. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of chemotherapy. c. Active hepatitis C subjects as demonstrated by test for hepatitis C ribonucleic acid (RNA). Subjects who are HCV antibody positive will be screened for HCV RNA by any RT-PCR or by DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value. d. Positive serology for HTLV 1 or 2. Re-screening for infection disease markers is not required at baseline (prior to lymphodepleting chemotherapy).
  12. History of severe immune disease, including non-infectious pneumonitis, requiring steroids or other immunosuppressive treatments.
  13. Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis, (non-infectious) pneumonitis.
  14. Evidence or history of significant cardiac disease (such as, but not limited to, unstable angina pectoris, myocardial infarction within the prior 6 months, heart failure within 6 months, symptomatic congestive heart failure, symptomatic or uncontrolled arrhythmias, severe aortic stenosis, symptomatic mitral stenosis).
  15. QTc > 450 msec or QTc > 480 msec for subjects with bundle branch block. Note: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used.
  16. Evidence or history of other significant, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study.
  17. Subjects with concomitant second malignancies (except adequately treated nonmelanomatous skin cancers, carcinoma in situ of the breast, treated superficial bladder cancer or prostate cancer, or in situ cervical cancers) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period. Long-term adjuvant therapy (example: breast cancer) is acceptable.
  18. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  19. Active bacterial or systemic viral or fungal infections.
  20. Pregnant or breastfeeding.
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: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03168438
Other Study ID Numbers  ICMJE 208470
ADP-0011-008 ( Other Identifier: Adaptimmune Therapeutics )
KEYNOTE-487 ( Other Identifier: Merck )
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2020

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