Resources

Open Trials- March 2021

BREAST STUDIES:

SGNTUC-016

(Seattle Genetics)

Her2+ Breast Cancer – locally Advanced/metastatic

Central HER2 testing required prior to screening

Prior Taxane & Trastuzumab required

ECOG 0-1

Measurable or non-measurable disease assessable per RECIST 1.1

no prior tx w/T-DM1

 

DCISionRT Registry

(Prelude Dx)

DCIS

Histologic confirmed DCIS in a single breast

DCISionRT testing as SOC

planning breast-conserving surgery

eligible for radiation / systemic tx

25 years or older

invasive breast cancer excluded

no prior invasive or insitu breast cancer

Registry trial – Objective

Identify a statistically significant difference in physician treatment recommendations for patients diagnosed with DCIS and treated with breast conserving surgery based on availability of the DCISionRT test results (biologic factors)

Now Available at all Research sites w/radiation

 

IPI-549-03

(Infinity Pharmaceuticals)

Cohort A: TNBC – locally advanced or Metastatic

 Measurable disease per RECIST 1.1

ECOG 0-1

Screening biopsy required

No prior chemo or systemic therapy for locally adv. or mets TNBC setting

Cohort B: RCC – Closed

Treatments

 TNBC: IPI-549 PO + Front line therapy

(Atezolizumab + Nab-paclitaxel)


LUNG STUDIES:

AMG 510

 (20190436)

Expanded Access Study

 (Amgen)

Non small-cell lung cancerwith KRAS

p.G12C mutation

Ineligibility for participation in any ongoing clinical study of the investigational product

Have documentation of KRAS p.G12C mutation per local testing guidelines

Subjects will have exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy and PD-1/PD-L1 immunotherapy

 

LUNAR

EF-24

(Novacure)

Device study

Metastatic NSCLC- Stage 4

Next line after 1st Platinum failure in any setting

Prior EGFR/ALK tx ok if prior to platinum.

No current device in thorax

No brain mets.

(TTFields) concurrent with standard of care therapies.

Arm 1: docetaxel or immune checkpoint inhibitors Alone.

Arm 2: docetaxel or immune checkpoint inhibitors + TTFields.

TTFields application will be continuous with for at least 18 hours a day on Average.

 

Metis EF-25

(Novocure)

Device study

Phase 3/Brain mets from NSCLC

New diagnosis of brain metastases with 1 inoperable brain metastasis or 2-10 brain metastases, amenable to SRS.

Largest tumor volume < 10 cc.; longest tumor diameter < 3 cm; Cumulative volume of all tumors ≤ 15 cc

At least one measurable lesion

Karnofsky performance status (KPS) > 70

Leptomeningeal metastasis is exclusionary.

Patients that have received WBRT or prior SRS for their brain metastases will be ineligible for this study.

Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase

NovoTTF-100M device (150kHz output frequency)

Patients may continue on systemic therapy while receiving TTFields.

Patients on the supportive care arm can crossover to the device arm after second intracranial failure

Following first progression in the brain, patients may be offered salvage therapy based on local practice such as resection, repeat SRS or WBRT. (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto-oncogene, and proto-oncogene B-RAF

PACIFIC-4

D9103C00001

(Astra Zeneca)

Stage I to II NSCLC – T1 – T3N0M0

Medically inoperable or operable & refusing surgery or choosing SBRT

**SBRT as definitive tx during treatment period

ECOG 0 – 2

All comers for histology and PDL-1 Status

Patients with ultra-central tumors are not eligible

Double Blind, randomized 1:1

Durvalumab 1500mg IV Q 4 wks

up to 24 months

Or

Placebo IV Q 4 wks up to 24 months

 

GX41563 FLATIRON

(Genentech)

Prospective Clinico-Genomic (PCG) Study

Documented mNSCLC (StageIV or recurrent Metastatic disease)

Planned initiation of SOC systemic therapy regardless of line

Not participating in interventional clinical trial at time of consent

 

MK 7339-013 KEYLYNK

(Merck)

Phase 3/newly diagnosed untreated LS- SCLC

Untreated Stage I-III LS-SCLC with at least 1 measurable lesion

ECOG ≤ 1

Tumor tissue required, fresh preferred over archival

Group A: Platinum doublet + Pembro with standard thoracic BID RT or QD RT followed by Pembro + olaparib placebo

Group B: Platinum doublet + pembro w/ BID RT or  QD RT followed by pembro plus Olaparib

Group C: Platinum doublet + pembro placebo with BID RT or  QD RT followed by pembro placebo plus olaparib placebo

Standard thoracic RT (45 Gy in 30 twice-daily fractions over 3 weeks)

Once-daily RT (60 to 66 Gy in 33 daily fractions over 6 weeks)


LYMPHOMA STUDIES:

UNITY-NHL-205UTX-TGR-205

(TG Therapeutics)

Relapsed or refractory NHL –including:

Follicular (requires prior alkylating agent and CD20 Ab) and Marginal Zone (only requires prior CD 20 Ab) 

-Non-candidates for high dose chemo or transplant

-ECOG 0-2.

FL stage 2:   

Arm A: Ublituximab + TGR-1202

Arm B : TGR-1202 Monotherapy

Arm D : Ublituximab monotherapy

MZL stage 2: Ublituximab + TGR-1202

 

XPORT-DLBCL-30

(Karyopharm)

Phase 2/3 Relapsed Refractory DLBCL (ptts not intended for ASCT or CAR-T)

 pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (eg, FL)

Have received at least 1 but no more than 2 previous systemic regimens for DLBCL tx

measurable disease per Lugano

ECOG ≤ 2

primary refractory disease defined as no response or relapse within 3 months after ending 1st-line tx will be allowed on study (up to 20% of enrolled patients in each Phase)

 


MYLEOFIBROSIS STUDIES:

TRANSFORM-2

M20-178

(Abbvie)

Relapsed or refractory -(resistant to a JAK-2 inhibitor)

MF- previously treated with JAK-2 inhibitor therapy who have measurable splenomegaly and are not candidates for allogeneic-stem cell transplantation.

Arm A – Exp. group: ruxolitinib 10mg BID + navitoclax 100/200 mg QD

 Arm B – Control group: Best available therapy, options include ruxolitinib, hydroxyurea, PEG-interferon-α2, or danazol and fedratinib (where approved for relapsed/refractory MF).


PROSTATE STUDIES:

TALAPRO-2

C3441021

(Pfizer Inc)

Castration-resistant prostate cancer

-Asymptomatic or mildly symptomatic mCRPC (pain scale <5)

Surgically or medically castrated

-Documented bone or soft tissue metastasis

Progressive disease at entry of study

(PSA only progression ok).

-ECOG 0-1.

Randomized 1:1

Arm 1: Talazoparib 0.5mg orally+ Enzalutamide 160mg orally

 Arm 2: Placebo and Enzalutamide 160 mg orally


BILIARY TRACT CANCER:

MS200647-0055

(EMD Serano

Merck)

Locally Advanced or Metastatic BTC

 Including intrahepatic and extrahepatic CCA, gallbladder cancer, and ampulla of Vater cancer

Naïve to chemotherapy, immunotherapy, and interventional radiological treatment

Measurable disease per RECIST 1.1

ECOG 0-1

Tissue testing required

Hepatitis B/C must be on stable doses of anti-viral medications

Treatment

 Bintrafusp alfa/placebo + Gemcitabine and Cisplatin


COLORECTAL CANCER:

BESPOKE

20-041-NCP

(Natera)

Patients that have undergone surgery for stage II or III colorectal cancer

Planning or undergone surgical resection of adenocarcinoma of the colon or rectum

Pathologic stage II or III disease

ECOG performance status ≤ 2

Clinically eligible for chemotherapy

Observational Study:

Data will be collected for patients who have undergone surgery for stage II or III colorectal cancer (CRC) and will provide whole blood samples for routine care SIGNATERATM testing. Patients will receive SIGNATERATM test results and may be recommended for adjuvant chemotherapy or observation by their treating healthcare provider


SOLID TUMORS:

SGNLVA-005

(SeaGen)

Unresectable LA or Met solid tumors

ECOG ≤ 1

Extensive stage disease

Progressopm following Platinum based chemo, no more than 1 line of chemo

Negative EGFR, ALK, ROS, BRAF + other mutations

Prior PDL-1 treatment

Cohort 1: SCLC

Cohort 2: NSCLC-squamous

Cohort 3: NSCLC-nonsquamous

Cohort 4: HNSCC

Cohort 5: Esophoogeal-squamous

Cohort 6: Gastric and GEJ adenocarcinoma

Treatment:

Ladiratuzumab Vedotin