Back to results

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

favezelimab/pembrolizumab

regorafenib

TAS-102

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1),, Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
Has a life expectancy of at least 3 months, based on the investigator assessment.
Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
Has adequate organ function.

Exclusion Criteria:

Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
Has a history of acute or chronic pancreatitis.
Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
Has urine protein greater than or equal to 1g/24h.
A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
Has previously received regorafenib or TAS-102.
Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
Has a known history of human immunodeficiency virus (HIV) infection.
Has known history of Hepatitis B or known active Hepatitis C virus infection.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has had an allogenic tissue/solid organ transplant.

Sites / Locations

Georgetown University Hospital ( Site 1148)
Sibley Memorial Hospital ( Site 1143)
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)
Norton Cancer Institute ( Site 1139)
Rutgers Cancer Institute of New Jersey ( Site 1105)
Memorial Sloan Kettering Cancer Center ( Site 1703)
Oregon Health & Science University ( Site 1141)
MUSC Hollings Cancer Center ( Site 1715)
The West Clinic, PLLC dba West Cancer Center ( Site 1149)
UT Southwestern Medical Center ( Site 1709)
Intermountain Medical Center ( Site 1707)
Inova Schar Cancer Institute ( Site 1130)
VCU Health Adult Outpatient Pavillion ( Site 1712)
Blue Ridge Cancer Care ( Site 1718)
Seattle Cancer Care Alliance ( Site 1107)
Westmead Hospital ( Site 0057)
Royal Brisbane and Women s Hospital ( Site 0058)
Queen Elizabeth Hospital ( Site 0050)
Frankston Hospital ( Site 0056)
Western Health-Sunshine & Footscray Hospitals ( Site 0052)
St John of God Subiaco Hospital ( Site 0051)
London Regional Cancer Program - London HSC ( Site 0154)
The Ottawa Hospital ( Site 0151)
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)
Centro Investigacion Cancer James Lind ( Site 0204)
IC La Serena Research ( Site 0202)
Clinica Puerto Montt ( Site 0211)
Fundacion Arturo Lopez Perez FALP ( Site 0208)
Oncovida ( Site 0209)
Clínica Vespucio ( Site 0205)
Pontificia Universidad Catolica de Chile ( Site 0206)
Bradfordhill ( Site 0200)
The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Chongqing Cancer Hospital ( Site 1151)
Fujian Province Cancer Hospital ( Site 1178)
Sun Yat-Sen University Cancer Center ( Site 1150)
Southern Medical University Nanfang Hospital ( Site 1154)
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Hainan General Hospital ( Site 1177)
Wuhan Union Hospital Cancer Center ( Site 1162)
Hubei Cancer Hospital ( Site 1152)
Xiangya Hospital Central South University ( Site 1171)
Hunan Cancer Hospital ( Site 1174)
The Third Xiangya Hospital of Central South University ( Site 1175)
Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
Jilin Cancer Hospital ( Site 1163)
Jinan Central Hospital ( Site 1167)
Fudan University Shanghai Cancer Center ( Site 1176)
Shanghai Tenth People's Hospital ( Site 1170)
West China Hospital Sichuan University ( Site 1172)
Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
Zhejiang Cancer Hospital ( Site 1180)
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
Masarykuv onkologicky ustav ( Site 1203)
Fakultni nemocnice v Motole ( Site 1201)
Fakultni nemocnice Hradec Kralove ( Site 1207)
Fakultni nemocnice Olomouc ( Site 1204)
Fakultni nemocnice Kralovske Vinohrady ( Site 1208)
Fakultni Thomayerova nemocnice ( Site 1205)
Fakultni nemocnice Na Bulovce ( Site 1202)
CHU Bordeaux Haut-Leveque ( Site 0305)
CHU Hotel Dieu Nantes ( Site 0303)
Institut du Cancer Avignon-Provence ( Site 0306)
CHU Poitiers ( Site 0304)
Hopital Europeen Georges Pompidou ( Site 0300)
LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)
Philipps-Universitaet Marburg. ( Site 1252)
Klinikum Wolfsburg ( Site 1256)
Johanniter Krankenhaus Bonn ( Site 1254)
Kliniken Maria Hilf GmbH ( Site 1255)
Universitätsklinikum Halle ( Site 1251)
Katholisches Marienkrankenhaus gGmbH ( Site 1257)
Assuta Ashdod Public ( Site 0507)
Rambam Health Care Campus-Oncology Division ( Site 0500)
Bnei Zion Medical Center ( Site 0506)
Hadassa Ein Karem Medical Center ( Site 0504)
Rabin Medical Center ( Site 0503)
Chaim Sheba Medical Center ( Site 0501)
Sourasky Medical Center ( Site 0502)
Policlinico Gemelli di Roma ( Site 0552)
IRCCS Casa Sollievo della Sofferenza ( Site 0554)
Istituto Clinico Humanitas - Cancer Center ( Site 0555)
A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)
ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)
Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)
National Cancer Center Hospital East ( Site 0600)
Kagawa University Hospital ( Site 0608)
Kindai University Hospital ( Site 0607)
Saitama Prefectural Cancer Center ( Site 0603)
Shizuoka Cancer Center ( Site 0605)
National Hospital Organization Kyushu Cancer Center ( Site 0609)
National Cancer Center Hospital ( Site 0601)
Japanese Foundation for Cancer Research ( Site 0602)
Asan Medical Center ( Site 0650)
Seoul National University Hospital ( Site 0653)
Severance Hospital ( Site 0652)
Samsung Medical Center ( Site 0651)
Pantai Hospital Kuala Lumpur ( Site 1303)
Beacon Hospital Sdn Bhd ( Site 1305)
Institut Kanser Negara - National Cancer Institute ( Site 1302)
University Malaya Medical Centre ( Site 1301)
Akershus universitetssykehus ( Site 1352)
St Olavs Hospital ( Site 1354)
Universitetssykehuset i Nord Norge. ( Site 1355)
Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)
Oslo Universitetssykehus HF. Ulleval ( Site 1351)
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)
SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)
FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)
City Hospital #40 ( Site 0853)
Clinical Research Center of specialized types medical care-Oncology ( Site 0860)
Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)
SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (
Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)
Sandton Oncology Medical Group PTY LTD ( Site 1501)
Cape Town Oncology Trials Pty Ltd ( Site 1506)
Cancercare Rondebosch Oncology ( Site 1509)
Hospital Universitari Vall d Hebron ( Site 0900)
Hospital Sant Pau i la Santa Creu ( Site 0905)
Hospital Clinico San Carlos ( Site 0902)
Hospital Universitario 12 de Octubre ( Site 0901)
Hospital Universitario Virgen Macarena ( Site 0906)
Chang Gung Medical Foundation - Kaohsiung ( Site 0956)
China Medical University Hospital ( Site 0953)
National Cheng Kung University Hospital ( Site 0955)
National Taiwan University Hospital ( Site 0950)
Taipei Veterans General Hospital ( Site 0951)
Chang Gung Medical Foundation. Linkou ( Site 0952)
Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)
Acibadem Adana Hastanesi ( Site 1008)
Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)
Hacettepe Universitesi Tip Fakultesi ( Site 1003)
Ankara Sehir Hastanesi ( Site 1005)
Antalya Egitim ve Arastirma Hastanesi ( Site 1010)
Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)
MI Precarpathian Clinical Oncology Center ( Site 1654)
Ukrainian Center of Tomotherapy ( Site 1658)
Odessa Regional Clinical Hospital ( Site 1664)
University College London Hospitals NHS Foundation Trust ( Site 1056)
Royal Marsden NHS Foundation Trust ( Site 1064)
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)
Royal Marsden NHS Trust ( Site 1063)
University Hospital Coventry & Warwickshire ( Site 1062)
Velindre Cancer Centre ( Site 1058)
Leeds Teaching Hospitals NHS Trust ( Site 1050)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Favezelimab/Pembrolizumab

Standard of Care (Regorafenib or TAS-102)

Arm Description

Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.

Participants will receive 160 mg regorafenib orally daily on Days 1-21 of each 28-day cycle. Participants will also receive 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day treatment cycle.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.

Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR

The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

Number of Participants Who Experience at least One Adverse Event (AE)

An AE is 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.

Number of Participants Who Discontinue Study Treatment Due to an AE

An AE is 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. The number of participants who discontinue study treatment due to an AE will be reported.

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.

Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.

Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.

Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.

Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) & QoL combined score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.

Full Information

NCT ID

NCT05064059

First Posted

September 29, 2021

Last Updated

June 8, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05064059

Brief Title

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Official Title

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 10, 2021 (Actual)

Primary Completion Date

February 9, 2024 (Anticipated)

Study Completion Date

November 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1),, Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

None (Open-label)

Allocation

Randomized

Enrollment

432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Favezelimab/Pembrolizumab

Arm Type

Experimental

Arm Description

Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.

Arm Title

Standard of Care (Regorafenib or TAS-102)

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

favezelimab/pembrolizumab

Other Intervention Name(s)

MK-4280A

Intervention Description

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Intervention Type

Drug

Intervention Name(s)

regorafenib

Other Intervention Name(s)

STIVARGA®, REGONIX®

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

TAS-102

Other Intervention Name(s)

LONSURF®

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to death due to any cause.

Time Frame

Up to approximately 26 months

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)

Description

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.

Time Frame

Up to approximately 19 months

Title

Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR

Description

The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.

Time Frame

Up to approximately 19 months

Title

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

Description

Time Frame

Up to approximately 19 months

Title

Number of Participants Who Experience at least One Adverse Event (AE)

Description

An AE is 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.

Time Frame

Up to approximately 27 months

Title

Number of Participants Who Discontinue Study Treatment Due to an AE

Description

Time Frame

Up to approximately 24 months

Title

Description

Time Frame