Breast NeoplasmsPhase 2NCT06157892
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
A Phase 2 study testing disitamab vedotin and tucatinib in people with Breast Neoplasms and Gastroesophageal Junction Adenocarcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 135 sites in 10 countries.
Trial summary
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms
- What is being tested?
- disitamab vedotin and tucatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 135 sitesin 10 countries
- Study dates
- 20 May 2024to 28 Jul 2029
- Phase
- Phase 2
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
- General Inclusion Criteria
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Dose Escalation and Optimization Phase Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
- Locally-advanced, unresectable, or metastatic stage
Show all 48Show fewer
- Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
- Cohort A (HER2-Low Breast Cancer) Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of breast carcinoma
- Locally-advanced, unresectable, or metastatic stage
- HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
- Prior therapies requirements
- No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
- Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
- Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy
- Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease:
- Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR
- Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
- Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
- Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
- Cohort B (HER2+ Breast Cancer) Inclusion Criteria
- Histologically or cytologically confirmed diagnosis breast carcinoma
- Locally-advanced, unresectable, or metastatic stage
- HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
- Participants must have:
- Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
- Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
- No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
- Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
- Locally-advanced, unresectable, or metastatic stage
- HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
- Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
- Participants must have received:
- Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
- Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
- Prior anti-PD-(L)1 therapy is allowed
- No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
- Must not have received prior treatment with HER2 directed therapy
- Cohort D (HER2+ LA/mGC/GEJC) Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
- Locally-advanced, unresectable, or metastatic stage
- HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
- Participants must have:
- Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
- Prior T-DXd treatment is allowed
- Prior PD1 inhibitor therapy is allowed
- No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC
Who cannot join
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
- Prior therapy with ADCs with MMAE payload
- Prior therapy with tucatinib
- Active CNS and/or leptomeningeal metastasis.
- Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
- History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications
Trial locations and contacts
135 sites in 10 countries.
135 sites in 10 countries
United States77 sites
Georgia Cancer Specialists - Athens
Athens, Georgia, 30606
Georgia Cancer Specialists - Annex
Atlanta, Georgia, 30341
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, 30342
Georgia Cancer Specialists-Northside
Atlanta, Georgia, 30342
Northside Hospital, Inc.- Central Research Department
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, 07920
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
Georgia Cancer Specialists - Blairsville
Blairsville, Georgia, 30512
Massachusetts General Hospital.
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Georgia Cancer Specialists - Canton
Canton, Georgia, 30115
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376
Zangmeister Cancer Center
Columbus, Ohio, 43219
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725
MSK Commack.
Commack, New York, 11725
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Atlanta Cancer Care - Cumming
Cumming, Georgia, 30041
Georgia Cancer Specialists - Cumming
Cumming, Georgia, 30041
Georgia Cancer Specialists - Decatur
Decatur, Georgia, 30033
Suburban Hematology-Oncology Associates - Duluth
Duluth, Georgia, 30096
San Juan Oncology Associates
Farmington, New Mexico, 87401
Siteman Cancer Center - North County
Florissant, Missouri, 63031
Colorado West Healthcare System, dba Community Hospital
Grand Junction, Colorado, 81505
Colorado West Healthcare, dba Grand Valley Oncology
Grand Junction, Colorado, 81505
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina, 29607
Memorial Sloan Kettering - Westchester
Harrison, New York, 10604
MSK Westchester.
Harrison, New York, 10604
Saint Luke's Cancer Institute LLC
Kansas City, Missouri, 64111
Saint Luke's Hospital Investigational Pharmacy
Kansas City, Missouri, 64111
Suburban Hematology-Oncology Associates- Lawrenceville
Lawrenceville, Georgia, 30046
Investigational Drug Service
Long Island City, New York, 11101
Georgia Cancer Specialists - Macon
Macon, Georgia, 31217
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, 53792
Georgia Cancer Specialists - Marietta
Marietta, Georgia, 30060
Memorial Sloan Kettering - Monmouth
Middletown, New Jersey, 07748
MSK Monmouth.
Middletown, New Jersey, 07748
Memorial Sloan Kettering - Bergen
Montvale, New Jersey, 07645
MSK Bergen.
Montvale, New Jersey, 07645
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center - Main Hospital
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02459
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
UC Irvine Medical Center
Orange, California, 92868
Renown Regional Medical Center
Reno, Nevada, 89502
Providence Health and Services Washington and Montana
Renton, Washington, 98057
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94158
UCLA Department of Medicine - Hematology & Oncology
Santa Monica, California, 90404
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404
Harborview Medical Center
Seattle, Washington, 98104
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Memorial Hospital
Shiloh, Illinois, 62269
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center - South County
St Louis, Missouri, 63129
Moffitt Cancer Center - International Plaza
Tampa, Florida, 33607
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Moffitt McKinley Hospital
Tampa, Florida, 33612
Banner-University Medical Center Tucson Campus
Tucson, Arizona, 85704
Banner-University Medical Center Tucson Campus
Tucson, Arizona, 85719
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
Tucson, Arizona, 85719
University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
The University of Arizona Cancer Center-Main
Tucson, Arizona, 85724
Memorial Sloan Kettering- Nassau
Uniondale, New York, 11553
MSK Nassau.
Uniondale, New York, 11553
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
South Korea9 sites
Dong-A University Hospital
Busan, Other, 49201
Chungbuk National University Hospital
Cheongju-si, 28644
National Cancer Center
Goyang-si, Other, 10408
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Korea University Anam Hospital
Seoul, 02841
Severance Hospital Yonsei University Health System
Seoul, 03722
St. Vincent's Hospital, The Catholic University of Korea
Suwon, 16247
Spain9 sites
Quirén Salud Barcelona
Barcelona, 08023
Hospital Universitari Vall d´Hebron
Barcelona, 08035
Institut Catala d'Oncologia
Barcelona, 08908
Hospital Universitario de Basurto
Bilbao, 48013
Grupo Hospitalario QuironSalud
Erandio Bizkaia, 48950
Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
Madrid, 28050
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, 28050
Ecg Medica Sl
Valencia, 46004
Hospital Clinico Universitario de Valencia
Valencia, 46010
Italy8 sites
Istituto Europeo di Oncologia
Milan, Lombardy, 20141
Niguarda Ca' Granda Hospital
Milan, Lombardy, 20162
Humanitas Istituto Clinico Catanese
Misterbianco (CT), Sicily, 95045
A.O.U. Federico II
Naples, Campania, 80131
Azienda Ospedaliera Universitaria (AOU) Federico II
Naples, Campania, 80131
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.
Naples, Campania, 80131
A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia
Naples, 80131
Azienda Ospedaliera Universitaria Integrata di Verona.
Verona, Veneto, 37134
United Kingdom8 sites
St Bartholomew's Hospital
London, EC1M 6BQ
The Royal Marsden Hospital
London, SW3 6JJ
The Royal Marsden NHS Foundation Trust (RM)
London, SW3 6JJ
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4GJ
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Taiwan7 sites
National Cheng Kung University Hospital
Tainan, 704017
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100225
National Taiwan University Hospital
Taipei, 100
National Taiwan University Cancer Center
Taipei, 106
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
Australia5 sites
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston, Victoria, 3199
Slade Pharmacy Frankston
Frankston, Victoria, 3199
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston
Peter MacCallum Cancer Centre
Melbourne, 3000
Slade Health
Mount Waverley, Victoria, 3149
Japan5 sites
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Okayama University Hospital
Okayama, 700-8558
Showa University Hospital
Shinagawa-ku, Tokyo-to, 142-8666
Showa Medical University Hospital
Tokyo, 142-8666
Canada4 sites
BC Cancer Kelowna.
Kelowna, British Columbia, V1Y 5L3
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Germany3 sites
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
Berlin, 12203
Universitatsklinikum Essen
Essen, 45147
Heidelberg University Hospital and German Cancer Research Center
Heidelberg, 69120
About this study
Official title: A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.
Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.
Read more
This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.
This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.
This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
Read the detailed description
This clinical trial is to evaluate disitamab vedotin in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-expressing LA/mBC and LA/mGC/GEJC. Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 4 expansion cohorts in subjects with HER2-low LA/mGC/GEJC, HER2+ LA/mGC/GEJC, HER2-low LA/mBC, and HER2+ LA/mBC.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms, Stomach Neoplasms, Triple Negative Breast Neoplasms
- Being tested
- disitamab vedotin, tucatinib
- Keywords
- Breast Cancer, Gastric Cancer, GC, GEJ, HER2-Low Breast Cancer, HER2-Positive Breast Cancer, Seattle Genetics
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disitamab vedotinDrug
Also called RC48, RC48-ADC
Given into the vein (IV; intravenous)
tucatinibDrug
Also called TUKYSA, ONT-380, ARRY-380
300mg given twice daily by mouth (orally)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - Previously treated advanced GC/GEJC or breast cancer | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Optimization - HER2-low and HER2+ LA/mBC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Optimization - HER2-low and HER2+ LA/mGC/GEJC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Expansion - HER2-low LA/mBC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Expansion - HER2+ LA/mBC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Expansion - HER2-low LA/mGC/GEJC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
| Dose Expansion - HER2+ LA/mGC/GEJC | Experimental | disitamab vedotin + tucatinib Receives: Drug: disitamab vedotin; Drug: tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs) in dose escalation phase
Measured: Up to 28 days
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Measured: Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities
Measured: Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations
Measured: Through 30-37 days after the last study treatment: approximately 5 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Approximately 3 years
Secondary outcomes (7)
Duration of response (DOR) per RECIST v1.1 by investigator assessment
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Measured: Approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by investigator assessment
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1.
Measured: Approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
Measured: Approximately 5 years
Overall survival (OS)
The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the date of death due to any cause.
Measured: Approximately 5 years
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax)
Measured: Through 30-37 days after the last study treatment; approximately 5 years
PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Measured: Approximately 1 month
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin
Measured: Through 30-37 days after the last study treatment; approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start20 May 2024
- Primary completion28 Jul 2029 (estimated)
- Study completion28 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RemeGen Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157892
- Sponsor's protocol ID
- SGNDV-004
- Other IDs
- C5731004, 2023-507555-29-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.