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.

Part 1 and Part 2

Primary Objectives:

• To evaluate the safety and tolerability of IMP1734 as monotherapy and in combination with anti-cancer agents
• To determine the MTD (or MAD) and RDE as monotherapy and in combination with anti-cancer
  agents

Secondary Objectives:

• To characterize the plasma PK profile of single and multiple doses of IMP1734
• To assess preliminary anti-tumor activity of IMP1734 as monotherapy and in combination with anti-cancer agents

Part 3

Primary Objectives:

• To estimate the anti-tumor activity of IMP1734

Secondary Objectives:

• To further assess the anti-tumor activity of IMP1734
• To further evaluate the safety and tolerability of IMP1734

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.

Dose-Escalation Phase

Co-Primary Objectives:

• To assess safety and tolerability, including dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD; if no MTD is defined) of IMGN151 when administered intravenously
• To determine recommended Phase 2 dose (RP2D) for IMGN151

Secondary Objectives:

• To characterize the pharmacokinetics (PK) and immunogenicity of IMGN151
• To assess objective response rate (ORR) for IMGN151 using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• To assess duration of response (DOR) for IMGN151 using RECIST v1.1

Expansion Phase

Primary Objective:

• To assess ORR for IMGN151 using RECIST v1.1

Secondary Objectives:

• To characterize safety and tolerability for IMGN151
• To characterize the PK and immunogenicity of IMGN151
• To assess DOR for IMGN151
• To assess PFS for IMGN151

Primary Objective:

• The primary objectives of this study are to determine the MTD/RP2D and safety profile of
  AO-252 in patients with advanced TNBC, HGSOC, and endometrial cancer

Secondary Objectives:

• Determine antitumor activity of AO-252 as assessed by objective response rate (ORR),
  disease control rate (DCR), duration of response (DOR), time to progression (TTP), and
  time to response (TTR).
• Determine the pharmacokinetic (PK) profile of AO-252 including maximum plasma
  concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the
  plasma concentration-time curve (AUC) over the dosing interval.

Primary Objectives:

• To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities
  (DLTs) for combination of ATR inhibitor (M1774) and BET inhibitor (ZEN003694) in
  women with recurrent clear cell, endometrioid, and platinum resistant high grade serous
  ovarian carcinoma (HGSOC) and clear cell and endometrioid endometrial carcinoma
  irrespective of ARID1A status (PART I).
• To determine safety and tolerability in ARID1A pathogenic alteration (ARID1AMUT) and
  ARID1A wildtype (ARID1AWT) cohorts (ARID1A is an integral biomarker) in an
  expansion phase (PART II).
• To determine change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
  inhibition, integral biomarker) from pre-treatment and on-treatment tumor samples in
  ARID1AMUT and ARID1AWT expansion cohorts by immunohistochemistry (IHC) (PART
  II).

Secondary Objectives:

• To evaluate change in pharmacodynamic biomarker expression of cmyc (for BET inhibition,
  integrated biomarker) from pre-treatment and on-treatment tumor samples in ARID1AMUT
  and ARID1AWT expansion cohorts by Digital Spatial Profiling (DSP) (PART II).
• To evaluate change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
  inhibition, integrated biomarker) from pre-treatment and on-treatment tumor samples in
  ARID1AMUT and ARID1AWT expansion cohorts by DSP (PART II).
• To investigate if ARID1A protein by IHC and DSP correlates with ARID1A pathogenic
  alteration in pre-treatment tumor biopsy samples (PART II).
• To estimate objective response rate (ORR) and progression free survival (PFS) at 6 months in
  ARID1A pathogenic alteration and wildtype cohorts (PART II).

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 Objectives:

• To compare antitumor activity in ORR per
  Response Evaluation Criteria in Solid Tumor
  (RECIST) Guidelines version (v) 1.1 as assessed
  by blinded independent central review (BICR)
  in patients with incurable metastatic /
  recurrent HNSCC patients progressed on after
  anti-PD-1 and platinum containing therapy,
  treated with petosemtamab monotherapy vs
  investigator’s choice monotherapy
• To compare OS in patients with incurable
  metastatic / recurrent HNSCC progressed on
  after anti-PD-1 and platinum-containing
  therapy, treated with petosemtamab
  monotherapy vs investigator’s choice
  monotherapy

Secondary Objectives:

• To evaluate antitumor activity in ORR per
  RECIST v1.1 as assessed by investigator review
• To evaluate antitumor activity in DOR per
  RECIST v1.1 as assessed by BICR and
  investigator review
• To evaluate antitumor activity in TTR per
  RECIST v1.1 as assessed by BICR and
  investigator review
• To evaluate antitumor activity in PFS per
  RECIST v1.1 as assessed by BICR and by
  investigator review
• To evaluate antitumor activity in CBR per
  RECIST v1.1 as assessed by BICR and by
  investigator review
• To evaluate safety and tolerability of
  petosemtamab monotherapy
• To evaluate patient health-related quality of
  life (HRQL) using the European Organisation
  for Research and Treatment of Cancer (EORTC)
  validated Quality of Life of Cancer Patients
  Questionnaire (QLQ-C30)
• To evaluate patient HRQL using the updated
  EORTC validated Quality of Life of Head and
  Neck Cancer Patients Questionnaire (QLQH&N43)
• To characterize the PK of petosemtamab
• To characterize the population PK of
  petosemtamab
• To characterize the immunogenicity of
  petosemtamab