Clinical Trials Actively Recruiting

Primary Objective:

• To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.

Secondary Objectives:

• To evaluate the safety and tolerability associated with the combination of olaparib + pembrolizumab vs. olaparib alone as maintenance therapy.
• To evaluate the overall survival (OS) of patients treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
• To evaluate the overall response rate (ORR) by RECIST 1.1, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
• To evaluate the overall response rate (ORR) by immune RECIST, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
• To evaluate the duration of response (DoR) by RECIST 1.1 in patients treated with olaparib + pembrolizumab compared to olaparib alone.

Banking Objective:

• To bank tissue and blood specimens for future correlative studies.

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
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Primary Objectives:

• To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine
• To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine

Secondary Objectives:

• To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine
• To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine

PHASE 1

Primary Objectives:

• Assess safety and tolerability of NUV‑1511 in advanced solid tumors
• Identify recommended dosing schedule(s) and corresponding RP2D(s) for Phase 2

Secondary Objectives:

• Explore preliminary efficacy of NUV-1511
• Characterize the PK profiles of NUV-1511

PHASE 2

Primary Objectives:

• Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
• Confirm the optimal NUV-1511 dosing schedule, dose level, and target tumor types for further development

Secondary Objectives:

• Further evaluate the safety and efficacy of NUV-1511

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 characterize the safety and tolerability of different dose levels of ZL-1218 when administered as a single agent and in combination with pembrolizumab (200 mg IV Q3 week), including dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of ZL-1218.

Secondary Objectives:

• To assess the preliminary efficacy of ZL-1218 when administered as a single agent and in combination with pembrolizumab.
• To characterize the pharmacokinetics (PK) of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.
• To evaluate the immunogenicity of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.

Primary Objective:

• To evaluate the safety of the study treatments in Cohorts A and B

Secondary Objectives:

• To evaluate the efficacy of the study treatments in Cohorts A and B
• To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participant’s perspective

Primary Objective:

• To determine whether de-intensified chemoradiation for early stage SCCA is able to maintain excellent 2year disease control of 85% or higher while improving anorectal HRQL, compared to standard-dose CRT, as measured by the change in the FIQoL instrument coping/behavior domain from baseline to 1 year.

Secondary Objectives:

• To compare changes in patient-reported outcomes (as per FISI, PROMIS, IIEF, SVQ, and VAS/VuAS instruments) between the experimental and control arm.
• To compare patterns of failure (local and regional relapse versus distant; infield versus out-of-field of radiation), disease control, and overall survival between experimental and control arm.
• To correlate vaginal dilator use during radiation delivery with sexual function.
• To measure changes in serum total testosterone from baseline to up to 12 months after radiation.
• To validate the utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemo-radiation is appropriate.
• To determine whether an online, interactive educational tool (eContour) may improve the quality of radiation target delineation for anal cancer.
• To determine the incidence of and predictors for cardiovascular toxicity in patients receiving 5-FU or Capecitabine.

Primary Objectives:

• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression free survival (PFS) versus systemic chemotherapy alone.

Secondary Objectives:

• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone.
• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved objective response using RECIST v1.1 versus systemic chemotherapy alone.
• To evaluate toxicity profiles of the two regimens.

Primary Objectives:

• To assess the safety and tolerability of AB248 alone or in combination with pembrolizumab

Secondary Objectives:

• To assess the preliminary antitumor effect of AB248 alone or in combination with pembrolizumab
• To assess the PK of AB248 alone or in combination with pembrolizumab
• To assess the relationship between AB248 PK and biomarkers of pharmacodynamic response to AB248 alone or in combination with pembrolizumab
• To assess the immunogenicity of AB248 when administered alone or in combination with pembrolizumab