Services // Clinical Research

QUICK LOOK:

For all Oncology Trials
Contact Michelle Mackenzie, RN, OCN, CRC at 973-436-1755 or [email protected]

For all other Studies
Contact Kelly Ritter, LPN, CCRC at 908-721-5673 or [email protected]

Current active trials are listed below



Condition Study Name Criteria Additional Information
Adenocarcinoma 1st line Advanced Gastric or Gastroesophageal Junctional Adenocarcinoma with FGFR2b Overexpression
  • Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
  • FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
  • Candidate for mFOLFOX6 chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Bemarituzumab (FPA144)/Placebo at no cost during the course of the study
  • Cycle 1 will consist of a one-time dose of Bemarituzumab (FPA144) on day 8
  • Patients will receive all other study related procedures at little or no cost during the course of the study
  • No crossover allowed
Bile Duct Cancer Untreated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma with FGFR2 Rearrangement
  • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic
  • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Documented FGFR2 rearrangement
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive INCB054828 at no cost during the course of the study
  • Gemcitabine/Cisplat are considered SOC and will be charged to the patient’s insurance
  • Patients will receive study related care at no cost
  • The study involves 1 visit every 3 weeks
  • Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible allowed to cross over and receive pemigatinib.
Breast Cancer Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
  • Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • At least 6 months since prior treatment with curative intent and recurrence
  • At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
  • Able to provide biopsy tissue for biomarker analysis
  • No prior immune-oncology therapy
  • No pre-existing neuropathy of at least Grade 2
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Responses will be assessed by CT or MRI scan every 6 weeks for the 1st 6 months, then every 12 weeks
  • Patients will continue to receive SGN-LIV1A until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, or study termination by the sponsor.
  • Pembrolizumab may be administered for a maximum of 35 cycles
Breast Cancer Breast Cancer Biomarker Sample Collection

Inclusion Criteria:

  • Adult women from 25 years of age to below 75 years of age
  • Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
  • Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
  • Previous approved procedures to enroll patients: breast augmentation & cyst aspiration

Exclusion Criteria:

  • Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
  • Have had a breast biopsy performed during the 6 months prior to the study visit
  • Prior breast cancer diagnosis.
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients may receive reimbursement for participating
Breast Cancer Germline BRCA1/2 Mutation Patients with Early Triple Negative Breast Cancer
  • Germline BRCA 1/2 mutation positive
  • Women and men at least 18 years of age or older
  • Histologically confirmed invasive triple negative Breast Cancer
  • Tumor >1.5 cm.
  • No evidence of distant metastasis
  • Patients with inflammatory breast carcinoma are excluded
  • No prior treatment with a PARP inhibitor in any disease setting
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Patients will receive breast surgery 4-6 weeks after the last dose of talazoparib
Leukemia Relapsed/Refractory Chronic Lymphocytic Leukemia
  • Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  • CLL/SLL requiring treatment per 2008 IWCLL criteria
  • Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  • Measurable disease by CT/magnetic resonance imaging (MRI)
  • ECOG performance status of 0, 1, or 2
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib
  • Patients will receive Zanubrutinib/Ibrutinib at no cost during the course of the study
  • Patients will receive study related care at no cost

                       

Leukemia Acute Myeloid Leukemia
  • Diagnosis of previously-untreated AML
  • Positive for FLT3 mutation
  • Ineligible for intensive induction chemotherapy
  • Clinically active central nervous system leukemia are excluded
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive ASP2215 tablets at no cost during the course of the study
  • Patients will receive study specified care at no cost
  • Treatment should continue until the subject no longer receives clinical benefit from therapy in the opinion of the investigator, until unacceptable toxicity occurs or the subject meets another treatment discontinuation criterion.
Lymphoma Treatment Naïve Follicular Lymphoma
  • Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2, or 3) Ann Arbor Stage II, III, IV disease
  • Measurable disease
  • 70 years of age or older; subject 60-69 years of age with one or more comorbidity
  • Meets one or more Goupe d’Etude des Lymphomas Folliculaire (GELF) criteria
  • Study drug Ibrutinib/Placebo (4 capsules) is administered orally once daily
  • Rituximab 375mg/m^2 IV will be administered as per SOC
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
Lymphoma Untreated Mantle Cell Lymphoma
  • Men and women, ≥ 65 years of age.
  • Pathologically confirmed mantle cell lymphoma
  • Presence of radiologically measurable lymphadenopathy or extranodal lymphoid malignancy
  • ECOG performance status of ≤ 2.
  • No history of prior malignancy
  • If goal of therapy is tumor debulking before stem cell transplant pt is excluded
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive rituxan, bendamustine, acalabrutinib/placebo at no cost during the course of the study                
  • Patients will receive study related care at no cost
  • BR can be administered for a maximum of 6 cycles.
  • Patients who are tolerating treatment and not progressing will then receive monotherapy acalabrutinib/placebo and maintenance rituximab every 2 months x 12 additional doses
  • Subjects randomized to the control arm who have confirmed disease progression may be eligible to crossover to acalabrutinib monotherapy until disease progression
Lymphoma Classical Hodgkin Lymphoma
  • Men and women ≥ 18 years of age
  • Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
  • Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will be asked to complete periodic Patient Reported Outcome (PRO) questionnaires
Lymphoma Untreated Diffuse Large B-Cell Lymphoma – Enzastaurin + R-CHOP
  • Histologically-confirmed diagnosis of CD20-positive DLBCL between 18 and 75 years of age
  • IPI score of at least 3
  • A left ventricular ejection fraction ≥50% by ECHO or MUGA scan
  • No prior treatment – systemic or radiation- for lymphoma
  • No CNS involvement
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Enzastaurin will be provided to the patient
  • R-CHOP is standard of care
  • Treatment assignment will be unblinded after initial phase of treatment and patients randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years
  • PET Scan will be performed at baseline and after 6 cycles of R-CHOP
  • CT scans will be performed at baseline, after cycles 3 & 6 then as clinically indicated
  • Bone Marrow biopsy at screening and end of R-CHOP
  • Tumor Slides/block must be submitted for central review
Lymphoma Relapsed/Refractory Follicular Lymphoma
  • Histologically confirmed diagnosis of B-cell follicular lymphoma (grade 1, 2 or 3a) based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue
  • ≥ 2 prior systemic treatments for follicular lymphoma
  • Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy (such as rituximab, cyclophosphamide, doxorubicin, and prednisolone; rituximab, cyclophosphamide, vincristine, and prednisolone; or bendamustine plus rituximab)
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive study medication at no cost during the course of the study
  • Patients will receive study related care at no cost
  • Zanubrutinib will be administered orally – 160 mg BID
  • Obinutuzumab will be administered by IV on days 1, 8 and 15 of cycle 1, then on Day 1 of Cycles 2 through 6, then every 8 weeks thereafter (maximum total duration 30 months)
  • At the discretion of the investigator, patients in arm B will be eligible to receive crossover treatment with zanubrutinib plus obinutuzumab if they experience progression or their disease does not respond to therapy with a CR or PR after 12 cycles
Lymphoma Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) – MOR00208 + Bendamustine versus Rituxan + Bendamustine
  • Histologically confirmed relapsed or refractory DLBCL
  • Must have fresh/archived tissue to submit to central lab
  • Bidimensionally measurable disease
  • Received at least 1 but no more than 3 previous systemic therapy lines for the treatment of DLBCL.  At least one must have included a CD20-targeted therapy
  • Have not received CD19-targeted therapy or bendamustine
  • Not candidates for HDC and ASCT
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • MOR00208 will be supplied by the sponsor
  • Rituxan/Bendamustine will be SOC
  • CT N/C/A/P at screening, C 3, 5, 7 - then every 3 months
  • PET Scan is required at screening and cycle 6
  • Bone Marrow Biopsy required at screening
Lymphoma Previously Treated R/R FL, SLL, MZL and MCL

Inclusion Criteria:

  • Diagnosis of R/R NHL a including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma
  • Must not be a candidate for high-dose therapy or autologous stem cell transplant
  • Measurable disease, defined as at least 1 measurable disease lesion >1.5 cm
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Ublituximab and TGR-1202 at no cost during the course of the study
  • Patients are required to get periodic CT scans  
Lymphoma Untreated Advanced Follicular Lymphoma
  • Previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab plus chemotherapy
  • Histologically documented CD-20-positive FL
  • Candidate for obinutuzumab plus chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Obinutuzumab at no cost during the course of the study
  • Patients will receive 6-8 cycles of obintuzumab/chemotherapy every 21-28 days
  • Maintenance obinutuzumab monotherapy in patients who achieve at least a partial response, after induction therapy will be administered a dose of 1000 mg once every 8 weeks for 2 years or until disease progression 
Myelofibrosis Primary Myelofibrosis (MF), Post PV-MF, or Post ET-MF
  • Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
  • Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • MRI of spleen is required at screening, Weeks 12 & 24, then every 12 weeks until week 108
  • Patients will complete an electronic symptom diary daily through week 24
Myelofibrosis Primary Myelofibrosis (MF), Post PV-MF, or Post ET-MF + JAK inhibitor failure
  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  • Failure of prior treatment with JAK inhibitor (Part A) or ruxolitinib (Part B)
  • ECOG ≤ 2
  • Must have a spleen
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • KRT-232 will be supplied by the sponsor
  • Patients will continue KRT-232 until disease progression or lack of tolerability
  • MRI of Abdomen is required every 12 weeks
  • Bone Marrow aspirate and biopsy required at screening and week 24
Pancreatic Cancer Metastatic Pancreatic Cancer – 2nd line
  • Metastatic pancreatic adenocarcinoma which has progressed following a First-Line Gemcitabine regimen
  • Measurable disease per RECIST v.1.1
  • ECOG PS 0-1
  • Must not have received previous radiation therapy or surgery for the treatment of pancreatic cancer
  • Patients on Coumadin and not willing to change to LMWH are excluded
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive AM0010 at no cost during the course of the study                
  • Patients will receive study related care at no cost
  • FOLFOX will be administered as per SOC for 12 planned cycles
  • Subjects randomized to the treatment arm will continue AM0010 After discontinuation of FOLFOX
  • Crossover of patients from the FOLFOX only treatment arm into the FOLFOX plus AM0010 treatment arm is not permitted
Condition
Adenocarcinoma
1st line Advanced Gastric or Gastroesophageal Junctional Adenocarcinoma with FGFR2b Overexpression
Criteria
  • Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
  • FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
  • Candidate for mFOLFOX6 chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Bemarituzumab (FPA144)/Placebo at no cost during the course of the study
  • Cycle 1 will consist of a one-time dose of Bemarituzumab (FPA144) on day 8
  • Patients will receive all other study related procedures at little or no cost during the course of the study
  • No crossover allowed
Bile Duct Cancer
Untreated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma with FGFR2 Rearrangement
Criteria
  • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic
  • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Documented FGFR2 rearrangement
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive INCB054828 at no cost during the course of the study
  • Gemcitabine/Cisplat are considered SOC and will be charged to the patient’s insurance
  • Patients will receive study related care at no cost
  • The study involves 1 visit every 3 weeks
  • Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible allowed to cross over and receive pemigatinib.
Breast Cancer
Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Criteria
  • Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • At least 6 months since prior treatment with curative intent and recurrence
  • At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
  • Able to provide biopsy tissue for biomarker analysis
  • No prior immune-oncology therapy
  • No pre-existing neuropathy of at least Grade 2
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Responses will be assessed by CT or MRI scan every 6 weeks for the 1st 6 months, then every 12 weeks
  • Patients will continue to receive SGN-LIV1A until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, or study termination by the sponsor.
  • Pembrolizumab may be administered for a maximum of 35 cycles
Breast Cancer
Breast Cancer Biomarker Sample Collection
Criteria

Inclusion Criteria:

  • Adult women from 25 years of age to below 75 years of age
  • Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
  • Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
  • Previous approved procedures to enroll patients: breast augmentation & cyst aspiration

Exclusion Criteria:

  • Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
  • Have had a breast biopsy performed during the 6 months prior to the study visit
  • Prior breast cancer diagnosis.
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients may receive reimbursement for participating
Breast Cancer
Germline BRCA1/2 Mutation Patients with Early Triple Negative Breast Cancer
Criteria
  • Germline BRCA 1/2 mutation positive
  • Women and men at least 18 years of age or older
  • Histologically confirmed invasive triple negative Breast Cancer
  • Tumor >1.5 cm.
  • No evidence of distant metastasis
  • Patients with inflammatory breast carcinoma are excluded
  • No prior treatment with a PARP inhibitor in any disease setting
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Patients will receive breast surgery 4-6 weeks after the last dose of talazoparib
Leukemia
Relapsed/Refractory Chronic Lymphocytic Leukemia
Criteria
  • Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  • CLL/SLL requiring treatment per 2008 IWCLL criteria
  • Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  • Measurable disease by CT/magnetic resonance imaging (MRI)
  • ECOG performance status of 0, 1, or 2
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib
  • Patients will receive Zanubrutinib/Ibrutinib at no cost during the course of the study
  • Patients will receive study related care at no cost

                       

Leukemia
Acute Myeloid Leukemia
Criteria
  • Diagnosis of previously-untreated AML
  • Positive for FLT3 mutation
  • Ineligible for intensive induction chemotherapy
  • Clinically active central nervous system leukemia are excluded
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive ASP2215 tablets at no cost during the course of the study
  • Patients will receive study specified care at no cost
  • Treatment should continue until the subject no longer receives clinical benefit from therapy in the opinion of the investigator, until unacceptable toxicity occurs or the subject meets another treatment discontinuation criterion.
Lymphoma
Treatment Naïve Follicular Lymphoma
Criteria
  • Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2, or 3) Ann Arbor Stage II, III, IV disease
  • Measurable disease
  • 70 years of age or older; subject 60-69 years of age with one or more comorbidity
  • Meets one or more Goupe d’Etude des Lymphomas Folliculaire (GELF) criteria
Additional Information
  • Study drug Ibrutinib/Placebo (4 capsules) is administered orally once daily
  • Rituximab 375mg/m^2 IV will be administered as per SOC
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
Lymphoma
Untreated Mantle Cell Lymphoma
Criteria
  • Men and women, ≥ 65 years of age.
  • Pathologically confirmed mantle cell lymphoma
  • Presence of radiologically measurable lymphadenopathy or extranodal lymphoid malignancy
  • ECOG performance status of ≤ 2.
  • No history of prior malignancy
  • If goal of therapy is tumor debulking before stem cell transplant pt is excluded
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive rituxan, bendamustine, acalabrutinib/placebo at no cost during the course of the study                
  • Patients will receive study related care at no cost
  • BR can be administered for a maximum of 6 cycles.
  • Patients who are tolerating treatment and not progressing will then receive monotherapy acalabrutinib/placebo and maintenance rituximab every 2 months x 12 additional doses
  • Subjects randomized to the control arm who have confirmed disease progression may be eligible to crossover to acalabrutinib monotherapy until disease progression
Lymphoma
Classical Hodgkin Lymphoma
Criteria
  • Men and women ≥ 18 years of age
  • Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
  • Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will be asked to complete periodic Patient Reported Outcome (PRO) questionnaires
Lymphoma
Untreated Diffuse Large B-Cell Lymphoma – Enzastaurin + R-CHOP
Criteria
  • Histologically-confirmed diagnosis of CD20-positive DLBCL between 18 and 75 years of age
  • IPI score of at least 3
  • A left ventricular ejection fraction ≥50% by ECHO or MUGA scan
  • No prior treatment – systemic or radiation- for lymphoma
  • No CNS involvement
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • Enzastaurin will be provided to the patient
  • R-CHOP is standard of care
  • Treatment assignment will be unblinded after initial phase of treatment and patients randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years
  • PET Scan will be performed at baseline and after 6 cycles of R-CHOP
  • CT scans will be performed at baseline, after cycles 3 & 6 then as clinically indicated
  • Bone Marrow biopsy at screening and end of R-CHOP
  • Tumor Slides/block must be submitted for central review
Lymphoma
Relapsed/Refractory Follicular Lymphoma
Criteria
  • Histologically confirmed diagnosis of B-cell follicular lymphoma (grade 1, 2 or 3a) based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue
  • ≥ 2 prior systemic treatments for follicular lymphoma
  • Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy (such as rituximab, cyclophosphamide, doxorubicin, and prednisolone; rituximab, cyclophosphamide, vincristine, and prednisolone; or bendamustine plus rituximab)
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive study medication at no cost during the course of the study
  • Patients will receive study related care at no cost
  • Zanubrutinib will be administered orally – 160 mg BID
  • Obinutuzumab will be administered by IV on days 1, 8 and 15 of cycle 1, then on Day 1 of Cycles 2 through 6, then every 8 weeks thereafter (maximum total duration 30 months)
  • At the discretion of the investigator, patients in arm B will be eligible to receive crossover treatment with zanubrutinib plus obinutuzumab if they experience progression or their disease does not respond to therapy with a CR or PR after 12 cycles
Lymphoma
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) – MOR00208 + Bendamustine versus Rituxan + Bendamustine
Criteria
  • Histologically confirmed relapsed or refractory DLBCL
  • Must have fresh/archived tissue to submit to central lab
  • Bidimensionally measurable disease
  • Received at least 1 but no more than 3 previous systemic therapy lines for the treatment of DLBCL.  At least one must have included a CD20-targeted therapy
  • Have not received CD19-targeted therapy or bendamustine
  • Not candidates for HDC and ASCT
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • MOR00208 will be supplied by the sponsor
  • Rituxan/Bendamustine will be SOC
  • CT N/C/A/P at screening, C 3, 5, 7 - then every 3 months
  • PET Scan is required at screening and cycle 6
  • Bone Marrow Biopsy required at screening
Lymphoma
Previously Treated R/R FL, SLL, MZL and MCL
Criteria

Inclusion Criteria:

  • Diagnosis of R/R NHL a including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma
  • Must not be a candidate for high-dose therapy or autologous stem cell transplant
  • Measurable disease, defined as at least 1 measurable disease lesion >1.5 cm
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Ublituximab and TGR-1202 at no cost during the course of the study
  • Patients are required to get periodic CT scans  
Lymphoma
Untreated Advanced Follicular Lymphoma
Criteria
  • Previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab plus chemotherapy
  • Histologically documented CD-20-positive FL
  • Candidate for obinutuzumab plus chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns
  • Patients will receive Obinutuzumab at no cost during the course of the study
  • Patients will receive 6-8 cycles of obintuzumab/chemotherapy every 21-28 days
  • Maintenance obinutuzumab monotherapy in patients who achieve at least a partial response, after induction therapy will be administered a dose of 1000 mg once every 8 weeks for 2 years or until disease progression 
Myelofibrosis
Primary Myelofibrosis (MF), Post PV-MF, or Post ET-MF
Criteria
  • Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
  • Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • MRI of spleen is required at screening, Weeks 12 & 24, then every 12 weeks until week 108
  • Patients will complete an electronic symptom diary daily through week 24
Myelofibrosis
Primary Myelofibrosis (MF), Post PV-MF, or Post ET-MF + JAK inhibitor failure
Criteria
  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  • Failure of prior treatment with JAK inhibitor (Part A) or ruxolitinib (Part B)
  • ECOG ≤ 2
  • Must have a spleen
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive study related care at no cost
  • KRT-232 will be supplied by the sponsor
  • Patients will continue KRT-232 until disease progression or lack of tolerability
  • MRI of Abdomen is required every 12 weeks
  • Bone Marrow aspirate and biopsy required at screening and week 24
Pancreatic Cancer
Metastatic Pancreatic Cancer – 2nd line
Criteria
  • Metastatic pancreatic adenocarcinoma which has progressed following a First-Line Gemcitabine regimen
  • Measurable disease per RECIST v.1.1
  • ECOG PS 0-1
  • Must not have received previous radiation therapy or surgery for the treatment of pancreatic cancer
  • Patients on Coumadin and not willing to change to LMWH are excluded
Additional Information
  • Patients will be directed to their own doctor for normal care/non-study related health concerns 
  • Patients will receive AM0010 at no cost during the course of the study                
  • Patients will receive study related care at no cost
  • FOLFOX will be administered as per SOC for 12 planned cycles
  • Subjects randomized to the treatment arm will continue AM0010 After discontinuation of FOLFOX
  • Crossover of patients from the FOLFOX only treatment arm into the FOLFOX plus AM0010 treatment arm is not permitted
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