Clinical Trials Actively Recruiting

Primary Objective(s):

• To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib with atezolizumab versus cabozantinib alone.
   

Secondary Objective(s):

• To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
• To compare RECIST objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
• To evaluate the quantitative & qualitive adverse events observed in each treatment arm.

Dual Primary Objectives:

• To compare progression-free survival (PFS) in frail or selected intermediate fit
  Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
  induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
  followed by Lenalidomide maintenance (Arm 2).
• To compare overall survival (OS) in frail or selected intermediate fit NDMM
  participants treated with VRd-Lite induction followed by lenalidomide maintenance
  (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
  hyaluronidase-fihj maintenance (Arm 3).

Secondary Objectives

• To compare PFS in Arm 1 versus Arm 3
• To compare OS in Arm 1 versus Arm 2.
• To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.
• To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.
• To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.
• To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.
• To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.

Primary Objective:

• To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

Secondary Objectives

• To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.
• To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.

Primary Objectives:

• To compare the progression-free survival in participants with relapsed/refractory
  large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD)
  or partial remission (PR) on first imaging response by central review (day +30
  PET/CT scan) after commercial CD19 CAR T-cell therapy who are randomized to
  receive each consolidation therapy versus those that receive no consolidation
  therapy (i.e. control). Specifically, to compare the PFS of 1) mosunetuzumab
  consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
  consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation

Secondary Objectives:

• To compare overall survival (OS) in participants randomized to each consolidation
  treatment arm versus control.
• To compare the complete remission (CR) conversion rate up to one year in
  participants randomized to each consolidation arm versus control.
• To evaluate the treatment-related adverse events in participants randomized to
  each consolidation arm.
• To evaluate the association between total metabolic tumor volume (TMTV), SUV
  max, and sum product (SPD) of diameters by PET-CT at first imaging response
  with complete remission conversion up to one year in participants randomized to
  each consolidation arm as well as those randomized to control.
• To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
  randomized to Arm 4 (observation) who have lymphoma progression within 12
  months of CAR T-cell infusion and subsequently ‘cross-over' to receive treatment
  with mosunetuzumab + polatuzumab vedotin.
• To estimate overall survival for all patients registered to this study.
• To assess the difference in overall survival between participants who achieved CR
  at first imaging (day +30) versus. those who did not achieve CR at first imaging.

Primary Objective:

• To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab.

Secondary Objectives:

• To compare pathologic complete response rates (ypT0/is, ypN0) in participants randomized to standard of care chemotherapy alone vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
• To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
• To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
• To compare overall survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
• To compare the frequency and severity of toxicities between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab among those who initiate the assigned treatment.

Primary Objectives

Among patients with metastatic extrapulmonary poorly differentiated small cell NEC, to compare overall survival (OS, measured from randomization) in a fixed sequence as follows:

• Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3)
• Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3)
• Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2)

Secondary Objective(s)

• To compare OS, measured from start of observation/maintenance, across arms
• To compare progression-free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms
• To compare objective response rate (ORR = confirmed and unconfirmed partial response (PR) + confirmed and unconfirmed complete response (CR)) across arms among patients with measurable disease at randomization
• To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease (SD)) across arms among patients with measurable disease at randomization
• To compare the duration of response (DOR) across arms
• To evaluate the safety and tolerability of each arm

Additional Objective

• To bank tumor and blood samples for future biomarker correlative studies

Co-Primary Objectives:

• To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.
• To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

Secondary Objectives:

• To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab.
• To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab.
• To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab.
• To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab.
• To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.

Primary Objective:

• To assess whether participants with early stage TNBC randomized to receive
  anthracycline-free, taxane-platinum neoadjuvant chemotherapy with
  pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS)
  compared to participants randomized to taxane-platinum-anthracycline
  neoadjuvant chemotherapy with pembrolizumab.

Secondary Objectives:

• To compare pathological complete response (pCR) and residual cancer burden
  (RCB) rates by randomized arm.
• To compare pCR and RCB rates between randomized arms by tumor infiltrating
  lymphocytes (TIL) status.
• To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL
  enriched subgroups.
• To compare distant relapse-free survival and overall survival by randomized arm.
• To compare invasive breast cancer-free survival after surgery between
  randomized arms in pCR and residual disease groups.
• To compare the safety and tolerability by randomized arm among those that initiate
  therapy.

Phase 1

Primary Objectives:

• Part 1 (Dose Escalation): Determine the RP2D(s) of bleximenib
• Part 2 (Dose Expansion): Determine safety and tolerability at the RP2D(s)

Secondary Objectives:

• Assess pharmacokinetics
• Assess preliminary clinical activity

Phase 2

Primary Objectives:

• To evaluate the efficacy of bleximenib at the RP2D

Secondary Objectives:

• To further assess the efficacy of bleximenib at the RP2D
• To evaluate MRD rate at the RP2D
• To assess the safety and tolerability of bleximenib at the RP2D
• To assess the effect of bleximenib on transfusion requirements
• To characterize PK of bleximenib at the RP2D
• To assess PROs with bleximenib at the RP2D

Phase I (dose escalation)

Primary Objectives:

• To identify the MTD and/or RP2D of ANV600 single agent and in combination with pembrolizumab

Secondary Objectives:

• To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing
• To evaluate the prevalence and incidence of immunogenicity of ANV600
• To describe the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Phase II

Primary Objectives:

• To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Secondary Objectives:

• To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab
• To assess the safety and tolerability ANV600 single agent and in combination with pembrolizumab for each cohort and in the overall study population
• To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing
• To evaluate the prevalence and incidence of immunogenicity of ANV600