A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

Study Overview

• Status: Terminated
• Conditions: Melanoma; Renal Cell Carcinoma; Cervical Cancer; Hepatocellular Carcinoma; Gastric Cancer; Pancreatic Cancer; Esophageal Cancer; Metastatic Cancer; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Advanced Cancer
• Intervention / Treatment: Drug: Alomfilimab; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Kymab investigational site 3602
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Kymab investigational site 3601
• Italy
  • Milano, Italy
    • Kymab investigational site 3901
  • Milano, Italy
    • Kymab investigational site 3903
  • Napoli, Italy
    • Kymab investigational site 3902
  • Roma, Italy
    • Kymab investigational site 3910
  • Turin, Italy, 10128
    • Kymab investigational site 3908
  • Forlì-Cesena
    • Meldola, Forlì-Cesena, Italy, 47014
      • Kymab investigational site 3904
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Kymab investigational site 3906
• Poland
  • Mazowieckie
    • Siedlce, Mazowieckie, Poland, 04-141
      • Kymab investigational site 4801
• Taiwan
  • Taipei, Taiwan
    • Kymab investigational site 8801
  • Changhwa
    • Changhua City, Changhwa, Taiwan, 505
      • Kymab investigational site 8806
• United Kingdom
  • London, United Kingdom
    • Kymab investigational site 4405
  • Manchester, United Kingdom
    • Kymab investigational site 4402
  • Oxford, United Kingdom
    • Kymab investigational site 4404
  • Sutton, United Kingdom
    • Kymab investigational site 4401
• United States
  • California
    • Duarte, California, United States, 91010
      • Kymab investigational site 1109
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Kymab investigational site 1102
  • Florida
    • Orlando, Florida, United States, 32806
      • Kymab investigational site 1108
    • Sarasota, Florida, United States, 34232
      • Kymab investigational site 1104
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Kymab investigational site 1103
  • Texas
    • Houston, Texas, United States, 77030
      • Kymab investigator site 1101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years (≥20 years in Taiwan)
• Histologically documented advanced/metastatic malignancies

• Phase 1 and Phase 2 participants with advanced/metastatic malignancies who have measurable disease (non-measurable disease is allowed only in Phase 1) as determined by RECIST 1.1 will be eligible if, according to the National Comprehensive Cancer Network (NCCN) guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled:

  1. Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer)
  2. Phase 2 Alomfilimab single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of Alomfilimab as single agent

  3. Phase 2 Alomfilimab in combination with atezolizumab: Participants with advanced/metastatic malignancies in the selected indications below, and/or indications which have shown promising activity in Phase 1:

     • NSCLC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
     • Gastric (anti-PD-(L)1 therapy naïve and pre-treated)
     • Recurrent and/or metastatic HNSCC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
     • Esophageal (anti-PD-(L)1 therapy naïve and pre-treated)
     • Cervical (anti-PD-(L)1 therapy naïve and pre-treated)
     • Indications, in which signs of anti-tumor activity has been observed in Phase 1 with Alomfilimab in combination with atezolizumab
• Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Life expectancy longer than 12 weeks
• Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a new tumor biopsy at screening, and during therapy on the study

Exclusion Criteria:

• Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks of first dose of study treatment
• History of severe hypersensitivity reactions to other monoclonal antibodies and/or their excipients
• Known presence of neutralizing anti-atezolizumab antibodies (for patients previously treated with atezolizumab)
• Having out of range laboratory values: creatinine, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), absolute neutrophil count (ANC), platelet count, hemoglobin

• Impaired cardiac function or clinically significant cardiac disease, including any of the following:

  1. Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia
  2. QTcF >470 msec on screening (electrocardiogram) ECG using Fridericia's formula (QTcF) or congenital long QT syndrome
  3. Acute myocardial infarction or unstable angina pectoris
• Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
• Malignant disease, other than that being treated in this study
• Any medical condition that would, in the Investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
• Active autoimmune disease or a documented history of autoimmune disease
• Participants previously exposed to anti-PD-(L)1 treatment who are not adequately treated for skin rash or had no replacement therapy for endocrinopathies should be excluded
• Participants with a history of drug-induced pneumonitis or current pneumonitis
• Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal, and ophthalmic steroids are not prohibited
• Use of live attenuated vaccines against infectious diseases within 4 weeks of the first dose of study treatment. SARS-CoV-2 vaccines authorized for use by the competent local regulatory health authorities for active immunization to prevent COVID 19 are allowed (unless the vaccine is live or live attenuated) and must be given in accordance with the prevailing immunization guidelines.
• Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment
• Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway
• Presence of Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) ≥Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE v5 ≥Grade 3) due to prior cancer therapy
• Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, participants enrolled in the Phase 2 part must have remaining measurable disease that has not been irradiated
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1: Alomfilimab Monotherapy; Participants will receive alomfilimab 0.8 to 240 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W).	Drug: Alomfilimab; A human anti-ICOS monoclonal antibody; Other Names: KY1044; SAR445256
Experimental: Phase 1: Alomfilimab + Atezolizumab Combination Therapy; Participants will receive alomfilimab 2.4 to 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.	Drug: Alomfilimab; A human anti-ICOS monoclonal antibody; Other Names: KY1044; SAR445256; Drug: Atezolizumab; An anti-PD-L1 monoclonal antibody; Other Names: TECENTRIQ
Experimental: Phase 2: Alomfilimab + Atezolizumab in Anti-PD-(L)1 Naïve Participants; Anti-PD-(L)1 naïve participants with pancreatic cancer, triple negative breast cancer (BC) or head and neck squamous cell carcinoma (HNSCC) will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.	Drug: Alomfilimab; A human anti-ICOS monoclonal antibody; Other Names: KY1044; SAR445256; Drug: Atezolizumab; An anti-PD-L1 monoclonal antibody; Other Names: TECENTRIQ
Experimental: Phase 2: Alomfilimab + Atezolizumab in Pre-treated Participants; Pre-treated participants with pancreatic cancer, triple negative BC or HNSCC will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.	Drug: Alomfilimab; A human anti-ICOS monoclonal antibody; Other Names: KY1044; SAR445256; Drug: Atezolizumab; An anti-PD-L1 monoclonal antibody; Other Names: TECENTRIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: resulted in death;; was life-threatening;; resulted in inpatient hospitalization or prolongation of existing hospitalization;; resulted in a persistent or significant disability/incapacity;; resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;; constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Number of Participants Experiencing Dose Changes	Dose changes were defined as infusion interruption and dose reduction.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Absolute Dose Intensity	Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Relative Dose Intensity	Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)	A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.	From first dose of study treatment (Day 1) up to 21 days
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1	ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Overall Response (BOR) Per RECIST 1.1	BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of: CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Not evaluable (NE).	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Progression-free Survival (PFS) Per RECIST 1.1	PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Duration of Response Per RECIST 1.1	Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response [CR or PR] + 1]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ORR Per iRECIST	RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
PFS Per iRECIST	PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Phase 1: ORR Per RECIST 1.1	ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.	From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks
Overall Survival Rate at 12 and 24 Months	Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method.	Months 12 and 24
Phase 2: Number of Participants Experiencing TEAEs	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that: resulted in death;; was life-threatening;; resulted in inpatient hospitalization or prolongation of existing hospitalization;; resulted in a persistent or significant disability/incapacity;; resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;; constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Number of Participants Experiencing Dose Changes	Dose changes were defined as infusion interruption and dose reduction.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Absolute Dose Intensity	Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Relative Dose Intensity	Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.	From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 1: Maximum Concentration (Cmax) of Alomfilimab	The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units.	Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Phase 1: Half-life (t1/2) of Alomfilimab	The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units.	Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime	Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated.	Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8	Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers. The summary of change in the following markers were calculated: FOXP3-ICOS double-positive cells per mm^2 in the Tumor; CD8-positive cells per mm^2 in the tumor; CD8-positive cells per mm^2 in the invasive margin.	Baseline and Cycle 2 Day 8 (21 day cycle length)

Collaborators and Investigators

• Sponsor: Kymab Limited
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): October 3, 2024
• Study Completion (Actual): October 3, 2024

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Urologic Neoplasms; Kidney Neoplasms; Carcinoma, Squamous Cell; Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Renal Cell; Triple Negative Breast Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Atezolizumab
• Other Study ID Numbers: KY1044-CT01; Sanofi Study ID (Other Identifier: TCD17370); 2018-003172-12 (EudraCT Number); U1111-1269-6777 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org

Drug and device information, study documents

• 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.: No