RESEARCH PROTOCOL UPDATE – November 2019
BRE 509 / SWOG – S1418
eoadjuvant Chemotherapy
A Randomized, Phase III Trial to
Evaluate the Efficacy and Safety of
MK-3475 as Adjuvant Therapy for
Triple Receptor Negative Breast Cancer
with ≥ 1 cm Residual Invasive Cancer or
Positive Lymph Nodes (>pN1mic) After
Neoadjuvant Chemotherapy
Version 7/30/19
NCT 02954874
BRE 510 / BI 1280-0022
Xenera-1: A multi-center, double-blind,
placebo-contr​o​lled, randomized phase
II trial to compare efficacy of
xentuzumab in combination with
everolimus and exemestane versus
everolimus and exemestane in
post-menopausal women with HR+ /
HER2- metastatic breast cancer and
non-visceral disease
Version Date 2/14/19
NCT 03659136
(Triple Negative) Kim Sydnor
PI – Dr. Shah
● Patients must have a complete axillary Observation versus Pembrolizumab
lymph node dissection after neoadjuvant IV q 3 weeks for 52 weeks
chemotherapy if pathologically node
positive before treatment or the removal
of only one sentinel node after the
completion of neoadjuvant chemotherapy.
● Patients can receive postoperative
chemotherapy for up to 24 weeks
● Patient must be registered within 90 days
of surgery for patients not receiving
postoperative chemo
● Patients must be registered within 270
days of surgery for patient receiving
postoperative chemo
● Radiation Therapy can be concurrent with
study treatment
● No autoimmune disease or Hepatitis
HR+ / HER2 – locally advanced / Kim Sydnor
metastatic breast cancer PI – Dr. Mitchell
● ER and / or PR positive HER2-negative Xentuzumab or placebo 1000 mg IV
locally advanced or metastatic breast q week + Evelolimus 10 mg daily +
cancer Exemestane 25 mg daily
● Disease progression during or within 12
months of completion of adjuvant therapy
with and AI or tamoxifen or disease
progression while on or within 1 month
after the end of AI therapy for advanced /
metastatic breast cancer
● No more than one prior line of
non-steroidal AI treatment for
advanced/metastatic breast cancer is
allowed. Prior treatment with one line of
CDK4/6 inhibitors is allowed.
● Prior treatment with fulvestrant is allowed
if duration was at least 2 years in the
adjuvant setting or at least 6 months in the
advanced/metastatic setting
● Postmenopausal at the time of consent
● Measurable or non-measurable disease
● ECOG 0-1 and adequate organ function
● Fasting glucose of < 8.9 or HbA1c < 8%,
Fasting triglycerides of ≤ 300mg/dL
● No previous treatment with agents
targeting IGF pathway, PI3K, ATK, or
mTOR pathways
● No evidence of visceral metastasis or CNS
involvement
1
 RESEARCH PROTOCOL UPDATE – November 2019
BRE 511 / [LEE011]: NATALEE).
A phase III, multicenter, randomized,
open-label trial to evaluate efficacy and
safety of ribociclib with endocrine
therapy as an adjuvant treatment in
patients with hormone
receptor-positive, HER2-negative, early
breast cancer
Archival tissue for submission
Version 2.o 6/20/19
NCT03701334
BRE 515 / NRG BR004
A Randomized, Double-Blind, Phase III
Trial of Paclitaxel / Trastuzumab /
Pertuzumab with Atezolizumab or
Placebo in First-Line HER2-Positive
Metastatic Breast Cancer
Tissue must be submitted for HER2, ER,
PR and PDL1 testing by a central
laboratory
Version 8/5/19
NCT03199885
HR+ HER2- Stage II Breast Cancer Sylvia Neff
PI – Dr. Khatcheressian
● Breast cancer unilateral invasive
adenocarcinoma dx within 18 months Ribociclib 400 mg q day 1-21 of a
prior to randomization 28 day cycle
● ER and/or PR positive, HER 2 negative
● Anatomic stage group II that is either N1 with Letrozole 2.5 mg or
or N0 (T2-3, N0) with G2-3 and/or anastrozole 1mg daily
Ki67≥20%, excluding grade 1
● If indicated patient has completed
neoadjuvant and / or adjuvant Goserelin 3.6 mg sub q every 4
chemotherapy weeks if premenopausal
● If indicated, patient has completed
adjuvant radiotherapy
● Patient can have started endocrine therapy
up to 12 months prior to randomization.
● ECOG 0-1 and adequate bone marrow and
organ function based on labs
● EGC: QTcF < 450 msec and resting HR
50-90 bpm
● No clinically significant uncontrolled heart
disease
● No concomitant strong inhibitors or
inducers of CYP3A4/5, systemic
corticosteroids within 2 weeks of
randomization
● No impaired GI function interfering with
drug absorption
HER2+First Line Metastatic Breast Kim Sydnor
Cancer PI – Dr. Shah
ECOG Performance Status of 0 or 1 Paclitaxel weekly with Herceptin +
Locally recurrent, unresectable or Pertuzumab +
metastatic disease HER + breast cancer Atezolizumab/Placebo q 3 weeks
● De novo metastatic disease
presenting without prior history of
HER2-positive breast cancer.
● Locally recurrent or metastatic
disease ≥ 6 months following prior
therapy
Measurable disease
TSH and AM cortisol WNL
The LVEF must be ≥ 55%
Patients with an asymptomatic LVEF decline
to < 40% during or after prior
HER2-targeted therapy are excluded
Asymptomatic treated CNS metastases are
allowed
No significant cardiac disease
No peripheral neuropathy ≥ grade 2
No autoimmune disease or
immunodeficiency
No history of pulmonary fibrosis or
pneumonitis
2
 RESEARCH PROTOCOL UPDATE – November 2019
BRE 516 / BMS CA2097FL
Nivolumab or Placebo with
Neoadjuvant Chemotherapy and
Adjuvant Endocrine Therapy in ER+
HER2-Breast Cancer
Version date 7/1/19
GI 506 / Alliance A021502
Randomized Trial of Standard
Chemotherapy Alone or Combined with
Atezolizumab as Adjuvant Therapy for
Patient with Stage III Colon Cancer and
Deficient DNA Mismatch Repair
Version 2/5/19
Mandatory Pathology Submission
NCT 02912559
ER + Neoadjuvant Breast Cancer Kim Sydnor
PI – Dr. Yellinedi
Localized invasive ER+ HER2- breast ductal Paclitaxel weekly x 12 with
carcinoma that meets one of the following nivolumab or placebo every 3
staging requirements: weeks
● Documented operable T1c-T2 Followed by
(tumor size or = 2 cm)
AC + nivolumab or placebo q 2 or 3
● clinical node stage cN1-cN2
weeks x 4
● Documented operable T3-4,
cN0-cN2 Surgery
● Grade 3 BC of ductal histology or
Grade 2 BC having ER expression of Nivolumab or nivolumab placebo q
1-9% 4 week x 7 + Endocrine therapy
No history of ipsilateral invasive BC at any
time.
No Multicentric BC (the presence of > 1
tumor in different quadrants of the breast).
No Bilateral invasive BC.
Patients must not have peripheral
neuropathy ≥ grade 1
Patients are excluded for cN3, cN3a, cN3b,
or cN3c clinical lymph node staging
No Participants with an active, known, or
suspected autoimmune disease.
Adjuvant colon cancer with dMMR Kim Sydnor
PI – Dr. Shah
● Stage III colon adenocarcinoma - Atezolizumab + mFOLFOX6 + x 12
completely resected cycles followed by Atezolizumab
● Presence of DNA Mismatch Repair alone x 13 cycles
(dMMR)
● ECOG ≤ 2 versus
● Adequate bone marrow and organ
function mFOFLOX 6 x 12 cycles
● No Hepatitis B or C or active autoimmune
disease
● No active pulmonary disease with
Hypoxia O2 sat < 85% on RA or <88% on
O2
● Concurrent steroid use (> 10 mg
prednisone / day) is prohibited
● No prior medical therapy (chemo, XRT,
immunotherapy, biologic or targeted
therapy) ​except​ one cycle of mFolFOX6
3
 RESEARCH PROTOCOL UPDATE – November 2019
GU 506 / A031501
AMBASSADOR
Phase III Randomized Adjuvant Study
of Pembrolizumab in Muscle Invasive
and Locally Advanced Urothelial
Carcinoma versus Observation
Histologically confirmed muscle
invasive urothelial carcinoma of the
bladder or upper tract
**MUST HAVE TISSUE SAMPLES
AVAILABLE FOR TESTING**
Version 10/25/18
NCT 03244384
CLARIFICATION
Histologically confirmed muscle
invasion urothelial tract or lymph
node positive
GU 507 / MK7902-11
Phase 3 Study of First Line
Pembrolizumab with or without
Lenvatinib in Urothelial Carcinoma in
Cisplatin-ineligible Participants Whose
Tumor Expresses PDL1 and Any
Platinum-ineligible Participants
Pathology sample (archival) available
for central analysis
Version date ​7/22/19
NCT03898180
Muscle Invasive Urotherial carcinoma of Kim Syndor
the bladder or upper tract PI – Dr. Shah
● Patient must fit into one of the following Observation versus Pembolizumab
categories: 200 mg IV q 3 weeks x 18 doses
● Patients who have received
neoadjuvant chemotherapy and
pathological stage at surgical resection
is ≥ pT2 and / or N+
● Patient who are not cisplatin eligible
and pathologic stage at surgical
resection is ≥pT3 or pN+
● Patients that has declined adjuvant
cisplatin based or other systemic
therapy and pathologic state at surgical
resection is ≥ pT3 or pN+
● Patient must have had radical surgical
resection of their bladder cancer ≥ 4 weeks
but ≤ 16 weeks prior to pre-registration
● No evidence of residual disease or
metastasis after surgery
● Must not be Stage IV
● ECOG must be ≤ 2
● No postoperative/adjuvant systemic
therapy
● No prior treatment PD-1/PD-L1 therapy
nced / Unresectable Urothelial Cancer Kim Sydnor
PI – Dr. McFarlane
● Advanced / unresectable or metastatic Pembrolizumab 200 mg IV q 3
urothelial carcinoma of the renal pelvis, weeks + Lenvatinib or placebo 20
ureter (upper urinary tract), bladder, or mg po q day
urethra.
● Both transitional and mixed
transitional/non-transitional cell histology
are allowed but transitional must he the
predominant histology
● Measurable disease
● Neoadjuvant and adjuvant platinum-based
chemotherapy is allowed id recurrence
occurs > 12 month from completion
● PD-L1 ≥ 10
● Cisplatin ineligible must meet one of the
following criteria:
ECOG PS 2
2) CrCL < 60 but >29
3) audiometric hearing loss
4) grade 2 neuropathy
● If patients are ineligible for Cisplatin and
Carboplatin PD-L1 can be negative
4
 RESEARCH PROTOCOL UPDATE – November 2019
GU 508 / MK7339-010
Phase 3 Study of Pembrolizumab Plus
Olaparib Versus Abiraterone or
Enzalutamide in mCRPC
Version 11/6/19.
Pathology for submission: 24 unstained
slides or block
NCT03834519
GU 509 / MK3474-921
A Phase 3, Randomized, Double-blind
Study of Pembrolizumab (MK-3475)
Plus Docetaxel Plus Prednisone versus
Placebo Plus Docetaxel Plus Prednisone
in Participants with
Chemotherapy-naïve Metastatic
Castration-Resistant Prostate Cancer
(mCRPC) who have Progressed on a
Next Generation Hormonal Agent
(NHA) (KEYNOTE 921)
Version date 10/31/19
Pathology for submission: 24 unstained
slides or block
NCT03834506
static Castration Resistant Prostate Cancer Sylvia Neff
– Prior chemotherapy required PI- Dr. Voelzke
● Metastatic prostate cancer with
progression while on androgen Pembrolizumab 200 mg q 3 weeks
deprivation therapy by PSA or (Max of 35 cycles) + Olaparib 300
radiographic progression mg po BID
● Patients must receive prior Taxotere
● Prior treatment with either abiraterone Versus
acetate or enzalutamide (but not both).
● No more than one previous Abiraterone 1000 mg q day with
chemotherapy regimen for mCRPC and Prednisone 5 mg BID or
have had PD during treatment. Enzalutamide 160 po q Day
● (ECOG) performance status of 0 or 1
● No autoimmune disease that has required
systemic treatment in past 2 years
● No GI disorder affecting absorption
● No pneumonitis that required steroids.
● HIV, Hep B and Hep C negative
● No immunodeficiency or concurrent use
of chronic systemic steroid
● No ascites or significant pleural effusion
● No seizure within 6 months or any
condition which predisposed to seizure
● No clinically significant cardiac disease
● No prior radio-pharmaceuticals
● No concurrent use of strong or moderate
inhibitors P450 (CYP)3A4.
static Castration Resistant Prostate Cancer Sylvia Neff
– No prior chemotherapy PI- Dr. Voelzke
Progression of metastatic prostate while on Docetaxel 75 mg/m2 q 3 weeks
androgen deprivation by means of one of (Max 10 cycles)
the following:
With or Without
● PSA progression
● Radiographic progression in soft Pembrolizumab 200 mg q 3 weeks
tissue (Max of 35 cycles)
● Appearance of 2 or more new bone
lesions on bone scan
No prior chemotherapy
Evidence of metastatic disease (bone or soft
tissue lesions)
Received prior treatment with either
abiraterone acetate or enzalutamide (but
not both) in the pre-chemotherapy mCRPC
ECOG performance status of 0 or 1
No active autoimmune disease,
immunodeficiency or receiving chronic
systemic steroid
No symptomatic CHF
5
 RESEARCH PROTOCOL UPDATE – November 2019
GU 510/ MK3474-641
KEYNOTE-641: A Phase 3, Randomized,
Double-blind Trial of pembrolizumab
Plus Enzalutamide Versus Placebo Plus
Enzalutamide in Participants with
Metastatic Castration-resistant
Prostate Cancer
Version date 9/5/19
NCT03834493
.
HEM 503 / VCU A041702
PHASE III STUDY OF IBRUTINIB
PLUS OBINUTUZUMAB with or
without
VENETOCLAX in Patients ≥ 70 WITH
CLL
Version 7/18/19
NCT03737981
No prior with radio-pharmaceuticals
Metastatic Castration Resistant Prostate Sylvia Neff
Cancer - No prior chemotherapy PI- Dr. Voelzke
Progression of metastatic prostate while on Enzalutamide 120 mg po daily
androgen deprivation by means of one of With
the following: Pembrolizumab 200 mg or Placebo
● PSA progression q 3 weeks (Max of 35 cycles)
● Radiographic progression in soft
tissue
● Appearance of 2 or more new bone
lesions on bone scan
Evidence of metastatic disease
ECOG performance status of 0 or 1
No active autoimmune disease,
immunodeficiency or receiving chronic
systemic steroid
No seizure within 6 months of or any
condition which predisposed to seizure
No significant cardiac disease
No prior treatment with radio
pharmaceuticals
No prior treatment with enzalutamide
No prior chemotherapy for MCRP
Sylvia Neff
First Line CLL > 70 Years of Age
PI – Dr. Shah
● ≥5x109 B lymphocytes flow cytometry Ibrutinib cycles 1 - 15+: 420 mg
● B cell surface markers of CD19 and CD20, daily
as well as the T-cell antigen CD5.
● Intermediate or high-risk Rai stage CLL. Obinituzumab: Cycle 1-6
Patients must need treatment defined by at
with or without
least 1 of the following criteria:
o marrow failure
Venetoclax: Cycle 3 - 14
o Massive progressive or symptomatic
splenomegaly
o Massive nodes or progressive or
symptomatic lymphadenopathy
o Autoimmune anemia and/or
thrombocytopenia
o Symptomatic or functional extranodal
involvement
o B symptoms
o Progressive lymphocytosis with a
lymphocyte doubling time < 6 months or an
increase of ≥ 50% over a 2 month period
● No prior therapy for CLL
● Age < 70 and ECOG PS 0-2
● Adequate cardiac, liver and renal function
6
 RESEARCH PROTOCOL UPDATE – November 2019
HEM 504 / VCU EA9161
A Randomized Phase III Study of the
addition of Venetoclax to Ibrutinib
and Obinutuzumab versus Ibrutinib
and Obinutuzumab in Untreated
Younger Patients with Chronic
Lymphocytic Leukemia (CLL)
Version 8/26/19
NCT03701282
VCU LUN 505 – ALLIANCE A151216 /
ALCHEMIST Trial
Main study
LUN 505 / A151216
Pathology is submitted for molecular
analysis
Version 10/18/19 - NCT 02194738
OPEN FOR NON-SQUAMOUS
HISTOLOGY ONLY
SUB STUDIES based on results
LUN 507 / A081105: EGFR positive
Version 9/27/19 – NCT02193282
LUN 506 / E4512: ALK positive
Version 2/8/19 – NCT02201992
● No current use of strong or moderate CYP
3A inhibitors or inducers
● No warfarin or other vitamin K
antagonists ion the proceeding 30 days
Kim Sydnor
First Line CLL ≤ 70 Years of Age
PI – Dr. Shah
CLL or SLL Ibrutinib cycles 1 - 15+: 420 mg
Negative FISH for t(11;14) or negative cyclin daily
D
Meets at least one of the following Obinituzumab: Cycle 1-6
indications for treatment
with or without
o Progressive marrow failure
o Symptomatic or progressive Venetoclax: Cycle 3 - 14
lymph-adenopathy
o One or more disease related symptoms
(weight loss, fatigue, fevers, night sweats
● Progressive lymphocytosis
● NYHA Classification < 3
● ECOG 0-2
● No deletion of 17p13 on Fish
● Adequate cardiac, liver and renal
function
● No concurrent use of steroids or
within 28 days
● No current use of strong or
moderate CYP 3A inhibitors or
inducers
● No warfarin or other vitamin K
antagonists
Sylvia Neff
ADJUVANT NSCLC
PI – Dr. Shah
● Completely resected stage IB (>or= 4 cm),
II or IIIA resected non-squamous SUB STUDIES – based on
● ECOG 0-1 molecular profiling
● Patient that received neo-adjuvant
chemotherapy or radiation are excluded ALK positive​: Crizotinib 250 mg
● No interstitial fibrosis or lung disease po bid versus Observation for up to
● Must have FFPE tissue block available for 2 years
EGFR and ALK genotyping
● Adequate bone marrow and organ EGFR positive​: Erlotinib mg po q
function day versus Observation for up to 2
Treatment initiation on sub study years
● Surgical resection alone - treatment on
sub study must start between 28 and
75days from resection
● Surgical resection followed by adjuvant
chemotherapy - treatment on sub study
must start within 225 days from
resection
● Surgical resection followed by adjuvant
chemotherapy and radiation therapy –
7
RESEARCH PROTOCOL UPDATE – November 2019
treatment on sub study must start within
285 days of resection

8
 RESEARCH PROTOCOL UPDATE – November 2019
LUN 513 / BDX-00100
The Clinical Effectiveness of VeriStrat
in Patients with NSCLC Who Are
Treated with Standard of Care
Therapies
Version 11/13/18
NCT03289780
LUN 518 / D9108C0001 (COAST)
A Phase 2, Open-label, Multicenter,
Randomized, Multidrug Platform Study
of Durvalumab Alone or in
Combination with Novel Agents in
Subjects with Locally Advanced,
Unresectable Stage III Nonsmall Cell
Lung Cancer
Version 8/27/19
Tumor tissue must be available for
submission
PROTOCOL AMMENDMENT
Must be randomized within 42 days
of completion of cCRT
NCT03822351
NSCLC prior to starting a new treatment Sylvia Neff
PI – Dr. Mitchell
for disease progression
● NSCLC – squamous or non-squamous Blood draw for Veristrat EGFR
● EGFR wild type or unknown status prior to starting a new
● Patient can be enrolled while on active treatment
treatment
● Evidence of active disease
e IIIA or IIIB NSCLC s/p combination chemo Kim Sydnor
(platinum doublet) + XRT PI – Dr. Mitchell
● Locally advanced unresectable stage III Control Arm:
NSCLC Durvalumab monotherapy q 28
● Subjects must have a least one previously days
irradiated tumor lesion that can be
measured by RECIST 1.1 Arm A:
● cXRT completed within 42 days of Durvalumab q 28 days +
randomization (platinum-based doublet) oleclumab q 14 days
● ECOG 0-1
● Adequate organ and bone marrow Arm B:
function Durvalumab q 28 days +
● No current or prior use of monalzumab q 14 days
immune-suppressive medications within
14 days before first dose
● No history of venous thrombosis within 3
months prior to randomization
● No history of grade 2 pneumonitis from
prior therapy
● No history of MI, TIA , or stroke within
the last 6 month
● No active primary immunodeficiency
● No significant cardiac disease
No prior exposure to any anti-PD-1,
anti-PD-L1, or anti-cytotoxic
T-lymphocyte-associated antigen-4
antibody treatment for NSCLC
9
 RESEARCH PROTOCOL UPDATE – November 2019
LUN 519 / GRN-1201-002
A Pilot, Open-Label, Multi-Center,
Multi-Dose Study of GRN-1201 Added
to Pembrolizumab in Subjects with
Non-Small Cell Lung Cancer with High
PDL-1 Expression
Version 9/18/19
Tumor tissue is required
Subjects with documentation of
PD-L1 TPS ≥ 50% by IHC
analysis using and FDA
approved test will not require
PD—L1 testing by central
laboratory
NCT03417882
LUN 520 / MK 7339-005
A Phase 3 Study of Pembrolizumab
with Etoposide/Platinum Followed by
Pembrolizumab with Maintenance
Olaparib/Placebo
Must have adequate tumor tissue
OPENING SOON
Line Stage IV NSCLC Sylvia Neff
PI – Dr. Shah
● Chemonaive for metastatic disease, GRN-1201 3 mg q week x 4 then q 3
adjuvant chemo is acceptable if > 6 weeks x 12 + Leukine 75 mcg +
months. Pembrolizumab 200 mg x 35 doses
● No prior anti-PDL1 or antiiPD-1
antibodies GRN-1201 administration:
● ECOG 0-1 Interdermal injections in proximity
● Measurable disease of axillary and inguinal lymph
● Adequate organ function nodes (upper arm upper thigh)
● No diagnosis of immunodeficiency or
receiving steroid therapy > 10 mg
prednisone or equivalent per day
● No active autoimmune disease that has
required systemic treatment in the past 2
years
● No history of interstitial lung disease or
pneumonitis
● No know history of Hep B or Hep C
● No significant cardiac conditions
● Not EGFR or ALK positive
Extensive Stage Small Cell Lung Cancer Sylvia Neff
PI – Dr. Shah
● Newly diagnosed extensive stage SCLC Etoposide + Platinum +
● Measurable disease Pembrolizumab x 4 cycles followed
● Pathology available for submission by Pembrolizumab + Olaparib or
● ECOG PS 0-1 placebo (31 cycles)
● No symptomatic pleural effusions
● No known history of interstitial lung
disease. Lymphangitic spread of the SCLC
is not exclusionary.
● No history of (non-infectious)
pneumonitis that required steroids or has
current pneumonitis.
● No diagnosis of immunodeficiency or is
receiving chronic systemic steroid
therapy
● No history of, or active, neurologic
paraneoplastic syndrome
10
 RESEARCH PROTOCOL UPDATE – November 2019
LUN 521 / LUNGMAP Screening
study
Protocol to Evaluate
Biomarker-Driven Therapies and
Immunotherapies in Previously
Treated NSCLC
Must have adequate tumor tissue
available for Foundation One analysis
Version 8/19/19
NCT03851445
e IV or recurrent NSCLC (all histologic Sylvia Neff
types) PI – Dr. Shah
Screening at progression​At least one line Submission of pathology specimen
of systemic therapy for any stage of disease for Foundation One analysis
(Stages I-IV) and must have progressed
during or following their most recent line of
therapy.
If prior systemic therapy was for Stage
I-III disease only disease progression on
platinum-based chemotherapy within one
year from the last treatment
For patients whose prior therapy was for
Stage IV or recurrent disease, the patient
must have received at least one line of a
platinum-based chemo or
anti-PD-1/PD-L1 therapy, alone or in
combination

Pre-Screening prior to progression on

current treatment
To be eligible for pre-screening, current
treatment must be for Stage IV or
recurrent disease and patient must have
received at least one dose of the current
regimen

● Patients with known EGFR mutations,

LUN 522 / S1800A
LUNGMAP SUBSTUDY
A Phase II Randomized Study of
Ramucirumab + Pembrolizumab versus
Standard of Care for Patients
Previously Treated with
Immunotherapy for Stage IV or
Recurrent NSCLC
Version 7/8/19
NCT03871474
ALK gene fusion, ROS 1 gene
rearrangement, or BRAF mutation are not
eligible unless they have progressed
G PS 0-1
e IV or recurrent NSCLC (all histologic types)
– Progression on prior anti-PD-1/PD-L1
therapy
● No active autoimmune disease or
immune-deficiency.
● Disease progress after1 line of anti-PD-1
or L1 as the most recent line of therapy
(alone or with chemotherapy. )
No ≥ Grade 3 immune-related AEs or
unresolved Grade 2 irAE.
● No history of pneumonitis or interstitial
lung disease
● No GI perforation or fistula within 6
months
● No gross hemoptysis within 2 months or
intratumor cavitation, evidence of major
blood vessel invasion or encasement
● No DVT ≤ 3 months. (stable dose of
anticoagulation therapy is allowed).
● No systemic corticosteroids or other
immunosuppressive medications
● No Chronic antiplatelet therapy
Sylvia Neff
PI – Dr. Shah
Arm A: Investigator’s Choice of
Standard of Care: Treating
Investigator and patient will choose
the appropriate SoC drug
(docetaxel, gemcitabine,
pemetrexed, or ramucirumab plus
docetaxel) based on patient’s
previous therapy and disease.
Arm B: Ramucirumab 10 mg/kg IV
over 60 minutes Day 1 Q 21 days
MK-3475 (Pembrolizumab) 200 mg
IV over 30 minutes Day 1 Q
21 days or up to 35 cycles
without disease
progression

11
 RESEARCH PROTOCOL UPDATE – November 2019
● ECOG performance status 0-1
LUN 523 / S1900A Sylvia Neff
Stage IV NSCLC – BRCA Postiive
LUNGMAP SUBSTUDY PI – Dr. Shah

A Phase II Study of Rucaparib in ● BRCA positive Rucaparib 600 mg po BID

Patient with BRAC Positive Stage IV or ● No prior treatment with any PARP Continuous
Recurrent NSCLC inhibitor
● Patients must not have a ≥ Grade 3
Version 3/19/19 hypercholesterolaemia
● Progression following the most recent
NCT03845296 line of therapy.
● Measurable disease
● ECOG performance status 0-1

Adjuvant HER 2 – Breast cancer Kim Sydnor

VCU A011401 / SUP 504
A011401 - Randomized Phase III Trial
Evaluating the Role of Weight Loss in
Adjuvant Treatment of Overweight and
Obese Women with Early Breast
Cancer
Version 3/4/19
NCT 02750826
VCU DCP-001 / SUP 505
Use of a Clinical Trial Screening Tool to
Address Cancer Health Disparities in
NCI Community Oncology Research
Program
Version 2/21/19
SUP 507 / 2018-01
Blood Sample Collection to Evaluate
Biomarkers in Subjects with
Untreated Solid Tumors
Supportive weight loss study PI – Dr. Shah
Dx of breast cancer within the past 14
months Arm 1
Her-2 negative 2 Year Health Education
If ER and PR negative: T2-3N0 or T0-3N1-3 Intervention
If ER and/or PR positive: T0-3N1-3, or T3N0 Weight Loss Group
(Patients with T1N1mi are not eligible)
All adjuvant or neo-adjuvant chemotherapy, ARM 2
surgery, and radiation completed at least 21 2 Year Health Education
days prior to registration Intervention + Supervised Weight
Patient with low or intermediate risk score Loss Intervention
do not have to received chemotherapy – can
be treated with endocrine therapy alone
Performance Status 0 or 1 Patients must be able to read and
No diabetes mellitus currently being treated comprehend English and walk at
with insulin or sulfonylurea drugs least 2 blocks
BMI ≥27 kg/m2 at enrollment
All patient screened for VCU Trial PI – Dr. Shah
All patients screened for NCORP clinical trial One time survey of information to
within 4 weeks of screening better understand the clinical trial
Cancer Diagnosis including stage and participation process
histology
Indication for study intervention
Untreated primary malignancy Kim Sydnor
PI – Dr. Choudhary
Colorectal, Bladder, Uterine, Kidney and One time blood draw
Renal Pelvis, Pancreatic, Liver, Stomach,
Ovarian, Esophageal

● No chemotherapy or radiation therapy

Protocol Version 2, Amendment 1, within the past 5 years
October 24, 2018 ● No treatment for primary malignancy or
metastases
NCT03662204​ ● Must be > 3 days from FNA of target
pathology
● Must be > 7 days from biopsy of target
pathology
● Must be > 1 day from CT

12
 RESEARCH PROTOCOL UPDATE – November 2019
SUP 508 / WF-97415 Adjuvant Breast Cancer Sylvia Neff
PI – Dr. Shah
Understanding and Predicting Breast Stage I-III female breast cancer (including Data Collection Time Points
Cancer Events after Treatment inflammatory and newly diagnosed, or
(UPBEAT) locally recurrent but not metastatic breast Baseline Labs /Data Collection +
cancer being treated with curative intent) Cardiac MRI

Scheduled to receive chemotherapy 1 Month Labs /Data Collection

ECOG performance status 0 – 2 3 Month Labs /Data Collection +

Cardiac MRI,
Able to undergo a cardiac MRI
12 Labs /Data Collection
If previously measured, known LVEF ≥ 50%
and no significant cardiac disease 24 Month Labs /Data Collection +
Cardiac MRI

Years 3 -11 Cardiac Event

Assessment

13