Clinical Trials Actively Recruiting

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.

Primary Objective:

• To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.

Secondary Objectives:

• To compare the overall response rate (ORR) by RECIST v1.1 criteria between arms;
• To compare overall survival (OS) between arms;
• To compare toxicity using CTCAE v5.0 criteria between arms;
• To assess patient-reported toxicity, as measured by the PRO-CTCAE, between arms, and explore patient-reported symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE.

Primary Objective:

• To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

Secondary Objectives:

• To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.
• To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
• To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
• To assess adverse events, graded using CTCAE v5.0.

Primary Objectives:

• To investigate the safety of monotherapy and T- Plex combination TCR-Ts
• To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Secondary Objectives:

• To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
• To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts

BGB-16673 Monotherapy Dose Finding (Phase 1)

Primary Objectives:

• To evaluate the safety and tolerability of BGB-16673 monotherapy
• To define the maximum tolerated dose (or maximum assessed dose) and the
  recommended Phase 2 dose (RP2D) of BGB-16673

Secondary Objectives:

• To characterize the pharmacokinetic profile of BGB-16673 as monotherapy
• To characterize the pharmacodynamic profile of BGB-16673 in peripheral blood
• To characterize the preliminary antitumor activity of BGB-16673 monotherapy

BGB-16673 Monotherapy (Phase 2)

Primary Objectives:

• To evaluate the antitumor activity of BGB-16673 monotherapy in patients with
  relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on overall response
  rate (ORR) as assessed by an Independent Review Committee (IRC)
• To evaluate the antitumor activity of BGB-16673 monotherapy in patients with R/R
  CLL/SLL based on ORR as assessed by investigators

Secondary Objectives:

• To evaluate the safety and tolerability of BGB-16673 monotherapy
• To further characterize the pharmacokinetic profile of BGB-16673
• To further characterize the pharmacodynamic profile of BGB-16673 in peripheral
  blood
• Patients with R/R MCL:
  • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR as
    assessed by investigators
  • To evaluate the antitumor activity of BGB-16673 monotherapy based on best
    overall response (BOR), time to response (TTR), duration of response (DOR), and
    progression-free survival (PFS) as assessed by the IRC and investigators
  • To characterize overall survival
  • To measure patient-reported outcomes (PRO) in R/R MCL patients via National
    Comprehensive Cancer Network Functional Assessment of Cancer Therapy –
    Lymphoma System Index-18 (NFLymSI-18)
• Patients with R/R CLL/SLL:
  • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR,
    DOR, TTR, and PFS as assessed by investigators
  • To characterize overall survival

Phase 1 Dose Escalation

Primary Objectives:

• To evaluate the safety and tolerability of CA-4948 in patients with R/R AML and
  hrMDS
• To identify the MTD and RP2D

Secondary Objectives:

• To characterize the PK parameters of CA-4948 using non-compartmental analysis
  and appropriate PK modelling
• To assess anti-cancer activity

Phase 2a Dose Expansion

Primary Objective:

• To assess anti-cancer activity of CA-4948 at RP2D in patients with R/R AML with
  FLT-3 mutations, and patients with R/R hrMDS or R/R AML with spliceosome
  mutations of SF3B1 or U2AF1

Secondary Objectives:

• To assess tolerability and long-term safety
• To further assess anti-cancer activity of CA-4948 at RP2D

Primary Objective:

• To evaluate the antitumor activity of nemvaleukin alfa (‘nemvaleukin’, ALKS 4230)in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancer

Secondary Objectives:

• To evaluate the antitumor activity of nemvaleukin in combination with pembrolizumab as compared with chemotherapy
• To evaluate the safety of nemvaleukin in combination with pembrolizumab as compared with chemotherapy

Primary Objectives:

• To evaluate the efficacy of selinexor compared to placebo as maintenance therapy

Key Secondary Objectives:

• To compare overall OS in selinexor and placebo arms

Secondary Objectives:

• To evaluate the safety and tolerability of selinexor
• To compare selinexor and placebo for time to first subsequent therapy
• To compare selinexor and placebo for time to second subsequent therapy
• To compare selinexor and placebo for time until second progression
• To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR)
• To evaluate health-related quality of life (HRQoL) outcomes

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.

Primary Objectives:

• Phase II: To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of progression-free survival (PFS).
• Phase III: To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of overall survival (OS).

Secondary Objectives:

• To further assess the efficacy of nivolumab compared with observation in terms of the relationship of baseline PD-L1 expression to clinical outcome.
• To evaluate the predictive value of HPV16 E6 and E7 DNA in saliva and plasma, at baseline, 12 weeks and 9 months after completion of radiation on PFS and OS in both arms of the study.
• To evaluate the tumor mutation burden by whole exome sequencing of the initial pretreatment tissue sample as well as samples obtained at the time of progression.
• To evaluate the association of 12 week post therapy FDG PET/CT with PFS and OS.
• To establish the prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
• To correlate SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative).
• To correlate the post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV DNA collected at the time of the standard 3 months PET/CT scan as well as 6 months later (i.e. 9 months post therapy) for both the observation and Nivolumab groups.
• To compare the PET based therapy response assessment (Hopkins criteria) to the RECIST 1.1 assessment at 12 week post chemoradiation therapy, for patients who have a PET/CT scan at 12 weeks.