Clinical Trials Actively Recruiting

Primary Objective:

• To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.

Secondary Objective:

• To summarize reports of serious and unexpected high-grade (≥ Grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.

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 assess the safety and tolerability of study drug
• To identify the recommended dose(s) (RD[s]) and schedule(s) that is (are) safe and biologically effective for study drug administered by intravenous (IV) dosing
• To identify the RD(s) and schedule(s) that is (are) safe and biologically effective for study drug administered by subcutaneous (SC) dosing

Secondary Objectives:

• To characterize the pharmacokinetics (PK) of study drug administered by IV dosing
• To characterize the PK of study drug administered by SC dosing
• To assess the preliminary antitumor activity of study drug

Dose Expansion Cohort 1 – Amivantamab SC Monotherapy

Primary Objectives:

• To assess anti-tumor activity of amivantamab monotherapy in
  participants with R/M HNSCC who have received prior
  treatment with platinum-based chemotherapy and a
  PD-1/PD-L1 inhibitor.

Secondary Objectives:

• To further assess anti-tumor activity of amivantamab
  monotherapy in participants with R/M HNSCC who have
  received prior treatment with platinum-based chemotherapy
  and a PD-1/PD-L1 inhibitor.
• To characterize safety and tolerability of amivantamab
  monotherapy in participants with R/M HNSCC who have
  received prior treatment with platinum-based chemotherapy
  and a PD-1/PD-L1 inhibitor.
• To characterize PK of amivantamab monotherapy in
  participants with R/M HNSCC who have received prior
  treatment with platinum-based chemotherapy and a
  PD-1/PD-L1 inhibitor.

Dose Expansion Cohort 2 – Amivantamab SC in Addition to Pembrolizumab

Primary Objectives:

• To assess anti-tumor activity of amivantamab in addition to
  pembrolizumab in participants with R/M HNSCC who are
  treatment-naïve in the R/M setting.

Secondary Objectives:

• To further assess anti-tumor activity of amivantamab in
  addition to pembrolizumab in participants with R/M HNSCC
  who are treatment-naïve in the R/M setting.

Dose Confirmation Cohort 3A– Amivantamab SC in Addition to Paclitaxel

Primary Objectives:

• Determine RP2CD(s) of amivantamab in addition to paclitaxel
  in participants with R/M HNSCC who have received
  PD-1/PD-L1 based therapy.
• To characterize safety and tolerability of amivantamab in
  addition to paclitaxel in participants with R/M HNSCC who
  have received PD-1/PD-L1 based therapy.

Dose Expansion Cohort 3B– Amivantamab SC in Addition to Paclitaxel

Primary Objectives:

• To assess anti-tumor activity of amivantamab in addition to
  paclitaxel in participants with R/M HNSCC who have
  received PD-1/PD-L1 based therapy.

Secondary Objectives:

• To further assess anti-tumor activity of amivantamab in
  addition to paclitaxel in participants with R/M HNSCC who
  have received PD-1/PD-L1 based therapy.
• To further characterize the safety and tolerability of
  amivantamab in addition to paclitaxel in participants with R/M
  HNSCC who have received PD-1/PD-L1 based therapy.

Primary Objectives:

• To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer

Secondary Objectives:

• To evaluate the safety and tolerability of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer
• To further evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer
• To characterize the surrogates of treatment effect

Primary Objective:

• To compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC

Secondary Objectives:

• To compare the combination of avutometinib plus defactinib vs ICT in patients with recurrent LGSOC with regard to additional efficacy parameters
• To characterize the safety and tolerability of combination avutometinib plus defactinib vs ICT in patients with recurrent LGSOC
• To determine the exposure of avutometinib and defactinib in patients with recurrent LGSOC treated with combination of avutometinib plus defactinib
• To assess the health-related quality of life and disease related symptoms in patients with recurrent LGSOC treated with combination avutometinib plus defactinib vs ICT

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.