Phase 2 Study of Lenvatinib+Pembrolizumab v SOC+Lenvatinib in HNSCC
Research type
Research Study
Full title
Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
IRAS ID
1003178
Contact name
Petra Jankowska
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Eudract number
2019-000569-19
Clinicaltrials.gov Identifier
Research summary
GENERAL BACKGROUND
This is a Phase 2, randomised, open-label three-arm clinical study to evaluate the safety
and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab
(MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in
participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M
HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1
inhibitors).
The study will be conducted in conformance with Good Clinical Practices (GCP).
PATIENT POPULATION
Approximately 400 male and female participants of at least 18 years of age, who have
progressed after platinum- containing chemotherapy and a PD-1-PD-L1 inhibitor will be
enrolled. Participants must have a histologically confirmed diagnosis of R/M HNSCC of
the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by
local therapies.
STUDY TREATMENT
This study is expected to last approximately 48 months from the time the first participant
signs the informed consent until the last participant’s last study-related telephone call or
visit.
The study is conducted in 3 phases, screening, intervention phase and a post intervention
phase. There is an optional crossover phase for participants randomised to standard of
care chemotherapy who experience verified progressive disease. There is also an
optional second course treatment phase for certain participants enrolled in the
pembrolizumab + Lenvatinib arm (Arm 1). They may be eligible for up to an additional
17 cycles of pembrolizumab with or without Lenvatinib.
Participants will be assigned randomly in a 3:3:2 ratio into 1 of the 3 treatment arms:
Arm 1:
Pembrolizumab 200 mg IV Infusion every 3 weeks (Q3W) for approximately 2 years (35
cycles) in combination with Lenvatinib 20mg oral dosage daily.
Arm 2: Investigator’s choice of SOC chemotherapy:
o Docetaxel – 75mg/m² IV infusion Q3W
o Capecitabine – 1250 mg/m² oral tablet twice a day on Day 1 of 14 of every 3-week
cycle
o Paclitaxel - 80mg/m² IV infusion on Day 1, 8 and 15 of every 3-week cycle
o Cetuximab 400 mg/m² loading dose followed by 250 mg/m² IV on Day 1, 8 and 15 of
every 3-week cycle
Arm 3: Lenvatinib monotherapy 24mg oral dosage daily.
A single-arm futility analysis for the lenvatinib monotherapy arm will be conducted after
30 participants have been randomized to lenvatinib monotherapy (Arm 3) and have been
followed up for approximately 12 weeks after study entry. Randomization to this arm will
be paused after the 30th participant is randomized. If the number of responses by BICR is
≥3, randomization to the lenvatinib monotherapy arm will be resumed such that a total of
N=100 participants will be enrolled in this arm. If the number of responses is ≤2,
randomization to the lenvatinib monotherapy arm will be permanently stopped. If the
number of responses by BICR ≥3 is observed prior to the 30th participant, the
randomization to the lenvatinib monotherapy arm will not be paused.
Randomisation will be stratified according to the following factors:
1. PD-L1 tumour expression as determined by PD-L1 immunohistochemistry (TPS <50%
versus ≥50%)
2. ECOG performance status (0 versus 1)
STUDY PROCEDURES
Screening
Written consent must be obtained before performing any protocol-specific procedures.
Results of a test performed before the participant signs the ICF as part of routine clinical
management are acceptable in lieu of a screening test if performed within the specified
time frame.
Screening procedures are to be completed within approximately 28 days before the first
dose of study intervention except for the following:
o The following laboratory tests are to be performed within 7 days before the first dose of
study intervention:
- CBC with differential
- Clinical Chemistry
- Urine Dipstick testing
- Urinalysis
- INR or PT and aPTT or PTT
- T3 or FT3, T4, TSH
o ECOG performance status is to be evaluated within 7 days before the date of the first
dose of study intervention.
o A full physical examination is to be performed within 10 days before start of study
intervention.
o For WOCBP, a urine or serum pregnancy test will be performed within 24 hours before
the first dose of study intervention. If urine pregnancy results cannot be confirmed as
negative, a serum pregnancy test will be required (performed by the local trial site
laboratory).
o Tumour tissue sample collection is not required to be obtained within 28 days prior to
randomization. Newly obtained tumour tissue may be obtained within 90 days of
treatment initiation. Tumour specimen must be received by the central vendor before a
participant is randomised. Repeat samples may be required if adequate tissue is not
provided.
o If additional time is needed for initial image submission and iCRO diagnostic quality
review, an extension of the screening window of up to 7 days may be approved following
mandatory Sponsor consultation.
Participants may be re-screened after initially failing to meet inclusion/exclusion
criteria. Results of assessments during the original screening period are acceptable in
lieu of repeat screening tests if obtained within the specified time frame and the
corresponding criteria are met. Re-screened participants will retain their original
screening numbers.
The following procedures may take place during the screening phase:
• Informed Consent
• Inclusion/exclusion criteria review
• Provision of participant identification card
• Review of demographics and medical history
• Prior/concomitant medication review
• Prior anticancer therapies for treatment of HNSCC review
• Submission of Pre-study Imaging
• Tumour Imaging (head and neck, chest and abdomen, imaging of the brain and pelvis
are optional) and Response Assessment
• AE/SAE Review
• height
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• MUGA or ECHO Scan (as clinically indicated)
• Eastern Cooperative Oncology Group (ECOG) performance status
• Serum β-HCG or Urine Pregnancy (WOCBP only)
• Laboratory procedures for blood samples
- HIV, Hepatitis B, and Hepatitis C screening
- Serum FSH for women of non-childbearing potential (WONCBP only)
Treatment Period
All eligible participants will be randomly allocated and will receive a
treatment/randomisation number. Intervention randomisation will occur centrally using
an interactive response technology (IRT) system. Participants will be assigned randomly
in a 3:3:2 ratio to pembrolizumab + lenvatinib (arm 1), SOC chemotherapy (arm 2) or
lenvatinib monotherapy (arm 3), respectively. Randomization will continue until the
planned number of participants in each arm receive at least 1 dose of study medication.
Participants in arm 1 will receive up to 35 administrations of pembrolizumab
(approximately 2 years).
The following procedures may take place during the initial treatment phase:
• Update of Participant Identification card (Day 1 visit)
• Review of prior/concomitant medication
• Randomisation
• Survival Status
• Lenvatinib dispensing (for participants in Arm 1 & 3)
• Treatment administration: (for participants in Arm 1 & 3)
o Pembrolizumab 200 mg (Q3W for 35 cycles)
o Lenvatinib 20 mg daily for the duration
• Treatment administration SOC Chemotherapy (for participants in Arm 2)
o Docetaxel
o Paclitaxel
o Cetuximab
o Capecitabine
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
• Directed physical examination
• Telephone contact
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Serum β-HCG or Urine Pregnancy (WOCBP only)
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Thyroid function tests (T3 or FT3, T4, TSH)
- Serum for Pembrolizumab PK and Anti pembrolizumab antibodies (ADA)
- Plasma for Lenvatinib PK
- Blood for genetic analyses, plasma biomarkers, serum biomarkers, RNA analysis and
circulating tumour nucleic acids.
• Urine dipstick testing
• Urinalysis
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQ-H&N35
Discontinuation of study intervention
Participants may discontinue study intervention at any time for any reason or be
discontinued from the study intervention at the discretion of the investigator should any
untoward effect occur. In addition, a participant may be discontinued from study
intervention by the investigator or the Sponsor if study intervention is inappropriate, the
study plan is violated, or for administrative and/or other safety reasons.
The following procedures may take place during the discontinuation of the treatment:
• Prior/Concomitant Medication Review
• Subsequent Anticancer Treatment
• Survival Status
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
• Full Physical Examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urine dipstick testing
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Blood for , plasma biomarkers, serum biomarkers, RNA analysis and circulating
tumour nucleic acids.
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQH&N35
WITHDRAWAL
A participant must be withdrawn from the study if the participant or participant’s legally
acceptable representative withdraws consent from the study. If a participant withdraws
from the study, they will no longer receive study intervention or be followed at scheduled
protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the
study, are outlined in Section 8.1.9 of the study protocol. The procedures to be performed
should a participant repeatedly fail to return for scheduled visits and/or if the study site
is unable to contact the participant are outlined in Section 7.3 of the study protocol.
Post treatment visits
SAFETY FOLLOW-UP VISIT
The mandatory Safety Follow-up visit should take place approximately 30 days after the
last dose of study intervention or before initiation of new anticancer treatment, whichever
comes first. Participants who are eligible for Second Course re-treatment may have up to
2 Safety Follow-up visits, 1 after initial treatment and 1 after Second Course treatment.
The following procedures may take place during safety follow-up visits:
• Prior/Concomitant Medication Review
• Subsequent Anticancer Treatment
• Survival Status
• AE/SAE Review
• Directed physical examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• MUGA or ECHO scan (Only for Arms 1 & 3)
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Thyroid function tests (T3 or FT3, T4, TSH)
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQH&N35
EFFICACY FOLLOW UP
Participants who complete the protocol-required cycles of study intervention or who
discontinue study intervention for a reason other than centrally verified PD will begin the
Efficacy Follow-up Phase and should be assessed as outlined in the Schedule of Activities
corresponding to the assigned treatment arm (Section 1.3 of the study protocol) to
monitor disease status. Every effort should be made to collect information regarding
disease status until the start of new anticancer therapy, centrally verified PD, death, end
of study, or the participant begins re-treatment as detailed in Section 8.10.2 of the study
protocol.
The following procedures may take place during efficacy follow up visits:
• Subsequent Anticancer Treatment
• Survival status
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
SURVIVAL FOLLOW UP
Participant survival follow-up status will be assessed approximately every 12 weeks until
death, withdrawal of consent, or the end of the study, whichever occurs first.
To ensure that current and complete survival data are available at the time of database
locks, updated survival data may be requested during the study by the Sponsor. Upon
Sponsor notification, all participants who do not or will not have a scheduled study visit
or study contact during the Sponsor-defined period will be contacted for their survival
status.
The following procedures may take place during survival follow up visits:
• Subsequent anticancer treatment
• Review of survival status
Crossover
Crossover Screening
Participants who experience centrally verified PD in the lenvatinib monotherapy (arm 3)
or SOC chemotherapy (arm 2) can crossover to receive pembrolizumab + lenvatinib at
time of disease progression with Sponsor approval. The following procedures may take
place during the crossover screening phase:
• Review of prior/concomitant medication
• Tumour Imaging (head and neck, chest and abdomen) and Response Assessment
• AE/SAE Review
• Full Physical Examination & height
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Serum β-HCG or Urine Pregnancy (WOCBP only)
• Laboratory procedures for blood samples
- Serum FSH for women of non-childbearing potential (WONCBP only)
- CBC with differential
- Clinical Chemistry
- Coagulation tests (PT/INR and aPTT or PTT)
- Thyroid function tests (T3 or FT3, T4, TSH)
• Urinalysis
• Urine Dipstick Testing
Crossover Treatment
Participants receiving lenvatinib monotherapy may add pembrolizumab to lenvatinib
upon centrally verified PD by RECIST 1.1 with Sponsor approval. Participants receiving
SOC chemotherapy may start pembrolizumab and lenvatinib upon centrally verified
radiographic PD by RECIST 1.1 with Sponsor approval.
The following procedures may take place during the cross over treatment period:
• Review of prior/concomitant medication
• Survival status
• Lenvatinib dispensing
• Treatment administration:
o Pembrolizumab 200 mg (Q3W for 35 cycles)
o Lenvatinib 20 mg daily for the duration
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI)
• AE/SAE Review
• Directed physical examination
• Telephone contact
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Serum β-HCG or Urine Pregnancy (WOCBP only)
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Thyroid function tests (T3 or FT3, T4, TSH)
- Serum for Pembrolizumab PK and Anti pembrolizumab antibodies (ADA)
- Plasma for Lenvatinib PK
- Blood for, plasma biomarkers, serum biomarkers, RNA analysis and circulating tumour
nucleic acids.
• Urine dipstick testing
• Urinalysis
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQH&N35
Discontinuation of study intervention
Participants may discontinue study intervention at any time for any reason or be
discontinued from the study intervention at the discretion of the investigator should any
untoward effect occur. In addition, a participant may be discontinued from study
intervention by the investigator or the Sponsor if study intervention is inappropriate, the
study plan is violated, or for administrative and/or other safety reasons.
The following procedures may take place during the discontinuation of the treatment:
• Prior/Concomitant Medication Review
• Subsequent Anticancer Treatment
• Survival Status
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
• Full Physical Examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urine dipstick testing
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Blood for plasma biomarkers, serum biomarkers, RNA analysis and circulating tumour
nucleic acids.
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQH&N35
WITHDRAWAL
A participant must be withdrawn from the study if the participant or participant’s legally
acceptable representative withdraws consent from the study. If a participant withdraws
from the study, they will no longer receive study intervention or be followed at scheduled
protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the
study, are outlined in Section 8.1.9 of the study protocol. The procedures to be performed
should a participant repeatedly fail to return for scheduled visits and/or if the study site
is unable to contact the participant are outlined in Section 7.3 of the study protocol.
SAFETY FOLLOW-UP VISIT
The mandatory Safety Follow-up visit should take place approximately 30 days after the
last dose of study intervention or before initiation of new anticancer treatment, whichever
comes first. Participants who are eligible for Second Course re-treatment may have up to
2 Safety Follow-up visits, 1 after initial treatment and 1 after Second Course treatment.
The following procedures may take place during safety follow-up visits:
• Prior/Concomitant Medication Review
• Subsequent Anticancer Treatment
• Survival Status
• AE/SAE Review
• Directed physical examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Thyroid function tests (T3 or FT3, T4, TSH)
• Patient reported outcomes (PRO)
- EQ-5D-5L
- EORTC QLQ-C30
- EORTC QLQH&N35
EFFICACY FOLLOW UP
Participants who complete the protocol-required cycles of study intervention or who
discontinue study intervention for a reason other than centrally verified PD will begin the
Efficacy Follow-up Phase and should be assessed as outlined in the Schedule of Activities
corresponding to the assigned treatment arm (Section 1.3 of the study protocol) to
monitor disease status. Every effort should be made to collect information regarding
disease status until the start of new anticancer therapy, centrally verified PD, death, end
of study, or the participant begins re-treatment as detailed in
Section 8.10.2 of the study protocol.
The following procedures may take place during efficacy follow up visits:
• Subsequent Anticancer Treatment
• Survival status
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
SURVIVAL FOLLOW UP
Participant survival follow-up status will be assessed approximately every 12 weeks until
death, withdrawal of consent, or the end of the study, whichever occurs first.
To ensure that current and complete survival data are available at the time of database
locks, updated survival data may be requested during the study by the Sponsor. Upon
Sponsor notification, all participants who do not or will not have a scheduled study visit
or study contact during the Sponsor-defined period will be contacted for their survival
status.
The following procedures may take place during survival follow up visits:
• Subsequent anticancer treatment
• Review of survival status
SECOND COURSE TREATMENT
Intervention Phase
Participants enrolled in the pembrolizumab + lenvatinib arm (Arm 1) who meet the
criteria outlined in Section 8.10.2 of the protocol may be considered for Second Course.
The following procedures may take place during the second course treatment period:
• Informed Consent
• Eligibility Criteria
• Prior/Concomitant Medication Review
• Survival Status
• AE/SAE review
• Full Physical Examination
• Directed Physical Examination
• Vital signs (resting BP, heart rate, respiratory rate and temperature) and weight
• 12-lead ECG with QTcF Determination (Only required for participants who receive
lenvatinib in the Second Course treatment phase.)
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Laboratory procedures for blood samples
- Coagulation tests (PT/INR and aPTT or PTT)
- CBC with differential
- Clinical chemistry
- T3 or FT3, T4, TSH
• Urine dipstick testing
• Urinalysis
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• Lenvatinib dispensing
• Treatment administration:
o Pembrolizumab 200 mg (Q3W for 17 cycles)
o Lenvatinib 20 mg daily for the duration
Discontinuation of study intervention
Participants may discontinue study intervention at any time for any reason or be
discontinued from the study intervention at the discretion of the investigator should any
untoward effect occur. In addition, a participant may be discontinued from study
intervention by the investigator or the Sponsor if study intervention is inappropriate, the
study plan is violated, or for administrative and/or other safety reasons.
The following procedures may take place during the discontinuation of the treatment:
• Prior/Concomitant Medication Review
• Subsequent Antineoplastic Therapy Status
• Survival Status
• Tumour Imaging (Head and neck, chest and abdomen) (CT or MRI) & response
assessment
• AE/SAE Review
• Full Physical Examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urine dipstick testing
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
WITHDRAWAL
A participant must be withdrawn from the study if the participant or participant’s legally
acceptable representative withdraws consent from the study. If a participant withdraws
from the study, they will no longer receive study intervention or be followed at scheduled
protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the
study, are outlined in Section 8.1.9 of the study protocol. The procedures to be performed
should a participant repeatedly fail to return for scheduled visits and/or if the study site
is unable to contact the participant are outlined in Section 7.3 of the study protocol.
SAFETY FOLLOW-UP VISIT
The mandatory Safety Follow-up visit should take place approximately 30 days after the
last dose of study intervention or before initiation of new anticancer treatment, whichever
comes first. Participants who are eligible for Second Course retreatment may have up to
2 Safety Follow-up visits, 1 after initial treatment and 1 after Second Course treatment.
The following procedures may take place during safety follow-up visits:
• Prior/Concomitant Medication Review
• Subsequent Antineoplastic Therapy Status
• Survival Status
• AE/SAE Review
• Directed physical examination
• Vital Signs (resting Blood Pressure, heart rate, respiratory rate, and temperature) and
weight
• 12-lead Electrocardiogram (ECG) with QT interval corrected with Fridericia’s
formula (QTcF) Determination
• MUGA or ECHO scan
• Eastern Cooperative Oncology Group (ECOG) performance status
• Pregnancy test – urine or serum (WOCBP only)
• Urinalysis
• Laboratory procedures for blood samples
- CBC with differential
- Clinical chemistry
- Thyroid function tests (T3 or FT3, T4, TSH)
EFFICACY FOLLOW UP
Participants who complete the protocol-required cycles of study intervention or who
discontinue study intervention for a reason other than centrally verified PD will begin the
Efficacy Follow-up Phase and should be assessed as outlined in the Schedule of Activities
corresponding to the assigned treatment arm (Section 1.3 of the study protocol) to
monitor disease status. Every effort should be made to collect information regarding
disease status until the start of new anticancer therapy, centrally verified PD, death, end
of study, or the participant begins re-treatment as detailed in Section 8.10.2 of the study
protocol.
The following procedures may take place during efficacy follow up visits:
• Subsequent Antineoplastic Therapy Status
• Survival status
• Tumour Imaging (Head and neck, chest and abdomen, imaging of brain and pelvis are
optional) (CT or MRI) & response assessment
• AE/SAE Review
SURVIVAL FOLLOW UP
Participant survival follow-up status will be assessed approximately every 12 weeks until
death, withdrawal of consent, or the end of the study, whichever occurs first.
The following procedures may take place during survival follow up visits:
• Review of subsequent anti-neoplastic therapy status
• Review of survival statusREC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0856
Date of REC Opinion
18 Sep 2020
REC opinion
Further Information Favourable Opinion