Oncology Clinical Trial List March 2023 - Breast
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Oncology Clinical Trial List
March 2023
Breast
*Post-menopausal females ≥ 18 years
*Histologically or cytologically confirmed ER+ and HER2 An Open-Label, Randomized, Non-
*ER andHER2 status must be documented: ER+ disease, with ER staining of Comparative Phase 2 Study of ARV-471
≥ 10% of tumor cell nuclei by IHC per ASCO/CAP Guidelines (Allison2020).
*HER2- disease by either IHC or in situ hybridization per ASCO/CAP
or anastrozole in Post-Menopausal
*Ki-67 score ≥ 5%, analyzed locally Women with ER+ HER2- Breast Cancer in
*Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical the Neoadjuvant setting
resection, without bilateralbreast ductal carcinoma in situ or invasive Arvinas ARV471-BC201 (TRIO048)
breast cancer
*Primary tumor must be at least 1.5 cm by imaging
Pending Site Activation
*ECOG performance status of 0 or 1
*Willing to undergo a screening biopsy, an on-treatment biopsy and
surgical resection
*Metastatic or locally advanced breast cancer not amenable to surgery or
radiotherapy.
*Currently receiving palbociclib and AI therapy in the metastatic setting
with evidence of progressive disease.
Phase 1b/2 Study of the Addition of
*Must have remained on palbociclib and AI therapy for ≥6 months for
advanced or metastatic breast cancer prior to evidence of progression that STAT3 Inhibitor TT1-101 to Reverse
treating physician believes warrants continued therapy with palbociclib Resistance on First Line Palbocilib Plus
and AI. Aromatase Inhibitor Therapy for
*Must be continuing on palbociclib at a dose of 125, 100, or 75 mg Metastatic Hormone-Receptor Positive
administered orally for 21 days every 28-day cycle. and HER2-Negative Breast Cancer
*All men and premenopausal women must be on medical gonadal
suppression therapy with a gonadotropin analog (e.g, goserelin or
Tvardi Therapeutics Inc. TVD-1001-
leuprolide) and have estrogen levels in the
postmenopausal range by institutional criteria at baseline. 0002B
*ECOG of 0 or 1.
*Documented histological or cytological hormone receptor-positive
(estrogen receptor-positive [ER+], human epithelial receptor 2-negative
[HER2-]) breast cancer per local lab test
*Only 1 prior line of systemic treatment (palbociclib and AI) in the locally
advanced or metastatic setting is allowed; the participant must have
shown evidence of progression on palbociclib and AI in the locally
advanced or metastatic setting prior to enrollment
*Willing to provide a representative fresh tumor tissue specimen prior to
enrollment, which must be obtained after evidence of progression on first-
line palbociclib and AI
*Measurable disease (RECIST) Version 1.1 is required
*Lesions in a previously irradiated area that have not progressed are not
considered measurable.
1Breast (Continued)
*Tumors are PD-L1 negative at screening or PD-L1 positive at screening
if they have received anti-PD-(L)1 inhibitor in the (neo)adjuvant setting A Randomized, Open-label, Phase 3
*Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue Study of Sacituzumab Govitecan Versus
*Must have completed treatment for Stage I-III breast cancer, if Treatment of Physician’s Choice in
indicated, and ≥ 6 months must have elapsed between completion of
Patients With Previously Untreated,
treatment with curative intent and first documented local or distant
Locally Advanced, Inoperable or
disease recurrence
*De novo metastatic TNBC are eligible Metastatic Triple-Negative Breast Cancer
*Measurable disease based on CT or MRI, RECIST 1.1, evaluated locally Whose Tumors Do Not Express PD-L1 or
*ECOG performance status of 0 or 1 in Patients Previously Treated With Anti-
*Adequate organ function PD-(L)1 Agents in the Early Setting
*HIV patients must be on antiretroviral therapy (ART) and have a well- Whose Tumors do Express PD-L1
controlled HIV infection/disease
Gilead GS-US-592-6238
*Treatment Period has 2 groups
*1 - tamoxifen concurrently with TOL2506
*2 - start with an AI (letrozole, anastrozole, or exemestane) 6
weeks after the first administration of TOL2506, upon A Phase 3, Single Arm, Open-Label Study
confirmation that estradiol (E2) levels of < 20 pg/mL have been Evaluating Ovarian Suppression
achieved. Following Three-Month Leuprolide
*After Week 12, subjects can switch from receiving an AI to Acetate Injectable Suspension (TOL2506)
receiving tamoxifen or from tamoxifen to AI at discretion of the in Combination with Endocrine Therapy
Investigator. in Premenopausal Subjects with
*Switch not permitted 28 days prior to a dosing visit. Hormone-Receptor–Positive (HR+),
*At the end of the Treatment Period, subjects eligible for Human Epidermal Growth Factor
compassionate use of TOL2506 (expanded access) until TOL2506 Receptor 2 (HER2)-Negative Breast
is commercially available. Cancer)
TolMar TOL2506A
*Untreated MBC HR+ Randomized Non-Inferiority Trial
*1 or more elevated breast markers (CEA, CA15-3, CA27.29) Comparing Overall Survival of Patients
*need at least 2 markers done Monitored with Serum Tumor Marker
*No brain mets Directed Disease Monitoring (STMDDM)
versus Usual Care in Patients with
Metastatic Hormone Receptor Positive
HER-2 Negative Breast Cancer
S1703 (NCORP)
*Single day chemo regimen and antiemetic Treatment of Refractory Nausea [during
*Read English chemo for breast cancer]
*> 3 nausea once to proceed to C2 URCC-16070 (NCORP)
*No Akynzeo
2Breast (Continued)
FDG PET to Assess Therapeutic Response
*Bone dominant MBC in Patients with Bone-Dominant
*Plan to receive 1st/2nd line ET, chemo or HER2 targeted therapy Metastatic Breast Cancer, FEATURE
*NO greater than 3 lines of tx EA1183 (NCORP)
ER+HER2- breast cancer
*Histol/cyto diagnosis of locally advanced or metastatic ER+HER2-
breast cancer, must have progressed after first line (first line depends A Phase 1 Dose Escalation and Expansion
on phase we are in) Study to Evaluate Safety, Tolerability,
*Documentation of ER-positive tumor (≥1% positive stained cells)
Pharmacokinetic, Pharmacodynamic,
based on most recent tumor biopsy
and Anti-tumor Activity of PF-07248144
*documentation of HER2-negative tumor: determined as
immunohistochemistry score 0/1+ or negative by in situ hybridization in Participants With Advanced or
*must be willing to undergo medically induced menopause by Metastatic Solid Tumors
treatment with the approved LHRH agonist such as goserelin, Pfizer C4551001
leuprolide or equivalent
*at least 1 measurable lesion as defined by RECIST version 1.1 not
previously irradiated.
*ECOG - PS 0 or 1
*Adequate renal, liver, and bone marrow function.
*Resolved acute effects of any prior therapy to baseline severity or
CTCAE Grade 1
CALLER Registry: Collaborative Attempt to Lower Lumpectomy Re-Excision Rates PI – Casey
Melanoma
*Merkel cell per AJCC 8th Ed. (Stage I-IIIb) STAMP: Surgically Treated Adjuvant Merkel
*8 Wks. Disease free prior to registration cell carcinoma with Pembrolizumab, a Phase
*NO prior tx. Before surgery III Trial
EA6174 (NCORP)
Urothelial
*MIBC (T2-T4AN0M0) Phase III Randomized Trial of Concurrent
*LN>10MM need bx. (suitable for neo-adj.) Chemoradiotherapy with or Without
*Staging & TURBT w/in 70days of rando. Atezolizumab in Localized Muscle Invasive
*NO prior tx. Bladder Cancer
*For MIBC
S1806 (NCORP)
*No radical cystectomy
Hematologic Malignancies
Collect data & treatment decisions by physicians using the Real World Observational Study using
clonoSEQ Assay for patients w/documented hematologic clonoSEQ® Next Generation Sequencing in
malignancy in: *MM; *ALL (B and T-cell subtypes); *B-cell *NHL Hematologic Malignancies: The ‘Watch’
(all sub-types) Registry
Adaptive Biotechnologies ADAP-008
3Anal and Colorectal
*Stage II-III colorectal cancer patients scheduled to receive oxaliplatin Duloxetine to Prevent Oxaliplatin-
510 mg/m² (cumulative dose) over 12 weeks as a component of Induced Chemotherapy-Induced
adjuvant FOLFOX Peripheral Neuropathy: A Randomized,
*Age ≥ 25 years. Double-Blind, Placebo-Controlled Phase
*Must be able to speak and read English
II to Phase III
A221805 (NCORP)
(Sub-study SI1 closed to enrollment)
A Randomized Phase III Study of Immune
*Patient must have inoperable, recurrent, or metastatic disease Checkpoint Inhibition with
*Measureable disease Chemotherapy in Treatment-Naïve
*No prior treatment for metastatic disease Metastatic Anal Cancer Patients
EA2176 (NCORP)
A Double Blind Placebo-Controlled Trial
of Eflornithine &Sulindac to Prevent
Enroll after Surgery alone or surgery and chemo/Rads Register 120 Recurrence of High Risk Adenomas and
days to 456 days after primary resection
Second Primary Colorectal Cancers in
Patients with Stage 0-III Colon or Rectal
Cancer, Phase III- Preventing Adenomas
of the Colon with Eflornithine and
Sulindac (PACES)
S0820 (NCORP)
*Histologically/cytologically confirmed Stage IV CRC with BRAF V600E An Open-label, Multicenter, Randomized
mutation Phase 3 Study of First line Encorafenib
*Prior systemic treatment in metastatic setting (considered metastatic Plus Cetuximab With or Without
treatment if relapse/ metastasis < 6 mos from end of adj/neoadj Chemotherapy Agents versus Standard
treatmnt
of Care Therapy with a Safety Lead-in of
*SLI: 0-1 regimens
Encorafenib and Cetuximab Plus
*Phase 3: None
*Measurable disease (Phase 3)/ Measurable or evaluable disease Chemotherapy In Participants with
(Safety Lead-in) Metastatic BRAF V600E Mutant
*ECOG PS 0-1 Colorectal Cancer
*Adequate organ function Pfizer C4221015
Non Small Cell Lung Cancer (NSCLC)
*Advanced stage (stages IIIB-IV) NSCLC and confirmed METex14 Disease Registry on Patients with
skipping alterations who are initiating or already treated with a Advanced Non-small Cell Lung Cancer
systemic therapy (NSCLC) Harboring METex14 Skipping
Alterations MOMENT (Met nOn sMall
cEll caNcer registry)
EMD Serono MS200095-0050
(MOMENT)
4NSCLC (Continued)
*Experimental: Arm A: LACP (Lazertinib, Amivantamab, Carboplatin, A Phase 3, Open-Label, Randomized
and Pemetrexed). After 4 cycles, Lazertinib, Pemetrexed, and Study of Amivantamab and Lazertinib in
Amivantamab as maintenance until PD Combination with Platinum-Based
*Active Comparator: Arm B: CP (Carboplatin and Pemetrexed) After 4 Chemotherapy Compared w/Platinum-
cycles, Pemetrexed as maintenance until PD
Based Chemotherapy in Patients with
*Experimental: Arm C: ACP (Amivantamab, Carboplatin and
EGFR-Mutated Locally Advanced or
Pemetrexed) After 4 cycles, Amivantamab and Pemetrexed as
maintenance until PD Metastatic Non-Small Cell Lung Cancer
After Osimertinib Failure
Janssen 61186372NSC3002 (Mariposa 2)
*Crizotinib A Randomized Phase III Trial for
*ALK Fusion Protein if ALK detected on Alchemist screening Surgically Resected Early Stage Non-
Small Cell Lung Cancer: Crizotinib Vs
Observation for Patients with Tumors
Harboring the Anaplastic Lymphoma
Kinase (ALK) Fusion Protein
E4512 [Alchemist ALK] (NCORP)
*Newly diagnosed stage IIIA/B/C NSCLC unresectable, Randomized Phase III Trial of MEDI4736
histologically/cytologically confirmed OR nodal recurrence after (Durvalumab) as Concurrent and
surgery for early stage NSCLC Consolidative Therapy or Consolidative
*Eligible w/nodal recurrence after surgery if no prior chemo/radiation Therapy Alone for Unresectable Stage 3
for this lung cancer, prior surgery was at least 90 days prior to nodal
NSCLC
recurrence, and no prior radiation that would cause overlap of
NCORP EA5181
treatment fields
*Measurable disease (RECIST 1.1)
* No autoimmune disease and neuromuscular paraneoplastic
syndromes
*No prior bone marrow or solid organ transplant; no past radiation to
current treatment site; no prior systemic treatment w/anti-
bodies/drugs targeting T-cell costimulation/immune checkpoint
inhibitors
*Review protocol for cardiac criteria
Oropharynx
*Oropharynx cancer (AJCC 8) that is p16-positive by with: ≥ 10 pack- A Phase III Randomized Study of
years, stage T1-2N2-N3 or T3-4N0-3 OR < 10 pack-years, stage T4N0-N3 Maintenance Nivolumab versus
or T1-3N2-3 Observation in Patients
*No prior systemic therapy, radiation, or surgery for p16 positive OPSCC with Locally Advanced, Intermediate
No previous radiation for head and neck, skull base, or brain
Risk HPV Positive OPSCC
*No distant metastases/leptomeningeal disease
NCORP EA3161
No uncontrolled inter-current illness interfering with the ability to
undergo therapy
*No history of prior/2nd malignancy
*Must have measurable disease, defined per protocol
5DNA Evaluation or Gene Sequencing
*Must have had/will have at least one dose of anti-PD-1/PD-L1 A Multicenter Cancer Biospecimen
immunotherapy Collection Study
*Must have had/will have tumor biopsy prior to anti-PD-1/PD-L1
treatment Cofactor Genomics, Inc. PREDAPT-2
*Must have had/will have CT or MRI of tumor prior to anti-PD-1/PD-L1
immunotherapy
*Must have enough tissue available for protocol needs
CANCERS
*Head and neck squamous cell carcinoma (HNSCC)
*Non-small-cell lung cancer (NSCLC)
*Small cell lung cancer (SCLC)
*Urothelial carcinoma (UCC)
*Gastric or gastroesophageal junction adenocarcinoma
*Cervical cancer
*Esophageal squamous cell carcinoma (ESCC)
*Triple-negative breast cancer (TNBC)
*Hepatocellular carcinoma (HCC)
*Renal cell carcinoma (RCC)
*Colorectal cancer (CRC)
*Surgically resected adenocarcinoma of the colon or rectum. BESPOKE Study of ctDNA Guided
*Within 6 weeks of surgery. Therapy in Colorectal Cancer
*Pathologic stage II or III disease Test Natera 20-041-NCP
*Documented metastatic, or locally advanced unresectable cancer – BESPOKE Study of ctDNA Guided
Melanoma; NSCLC; Colorectal Immunotherapy (BESPOKE IO)
*Must be clinically eligible and plan to initiate immunotherapy with an Natera 20-043-NCP (BESPOKE IO)
anti-neoplastic agent that works by immune checkpoint blockade, anti-
PD-1, anti-CTLA-4, or anti-PD-L1
**Cohort B - No Cancer - no cancer diagnosis or stable nodule for at DNA Evaluation of Fragments for Early
least 1 year by chest CT scan. (~70% no nodules and ~30% stable Interception - - Lung Cancer Training
nodules anticipated) Study
**Cohort C - Cancer, Non-Lung primary - pathologic diagnosis of non- DELFI-L101
lung cancer inclusive of TNM Stage, originating from: esophagus (Cohort A closed to enrollment)
(upper), colon or rectum, pancreas, stomach (including lower
esophagus), head & neck, bladder, kidney, or liver.
MDS, AML, CMML
MDS, AML, Idiopathic cytopenia of unknown significance Connect® MDS and AML: The Myelodysplastic
Within 60 days of diagnosis Syndromes (MDS) and Acute Myeloid Leukemia
(AML) Disease Registry
Celgene Connect AZA-MDS-006 Registry
Observational study A Non-interventional, Multinational,
*RRMM patients with at least 1 prior line Observational Study With Isatuximab in
*Prospective - Physician independent of study initiates isatuximab Patients With Relapsed and/or Refractory
per routine practice Multiple Myeloma (RRMM)
*Retrospective - Exposure to isatuximab for a max 3 months Sanofi OBS16577
6Rollover Studies
*Previously enrolled in a Pembrolizumab Study A Multicenter, Open label, Phase III Extension
Trial to Study the Long-term Safety and Efficacy
in Participants w/Advanced Tumors Who Are
Currently on Treatment or in F/up in a
Pembrolizumab Trial.
Merck MK-3475-587-00
Precision Medicine Basket Trials
Screening: Large 1B; IIA or IIB; NSCLC Squamous Stage IB – IIIA; Adjuvant Lung Cancer Enrichment Marker
Free testing for EGFR, ALK and PD-L1 Identification and Sequencing Trial
(ALCHEMIST)
A151216 (NCORP)
CONTACTS
For Research Information call: Investigators
Eileen Georgi, MSN RN - 954-267-7748 Ena Segota, MD
Brandon Barker, RN, BSN – 954-267-7718 David Drew, MD
Emmillio Depluzer, CRA - 954-229-8528 Georges Azzi, MD
Diana Christie, PharmD - 954-267-3036 Neil Nagovski, MD
Karim Arnaout, MD
Michel Velez, MD
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