Clinical Trials Actively Recruiting

Primary Objective:

• To determine the efficacy, based on PFS, of mFOLFOX6/bevacizumab plus atezolizumab (combination) as compared to single agent atezolizumab.

Secondary Objectives:

• To compare the overall survival
• To compare the objective response rates (ORR) per RECIST 1.1
• To determine the safety profiles of single agent atezolizumab and the combination of mFOLFOX6 bevacizumab/atezolizumab in patients with dMMR/MSI-H mCRC
• To determine the duration of response
• To determine the duration of stable disease
• To evaluate the rate of progression-free survival at 12 months
• To evaluate the disease control rate (CR + PR + SD) at 12 months

Primary Objectives:

• To determine if overall survival (OS) is improved with proton beam therapy (PBT) treatment as compared to intensity modulated radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer.
• To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT.

Secondary Objectives:

• To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and PROMIS-Fatigue;
• To compare the Quality-Adjusted Life Years (QALY) using EQ5D as a health outcome (Kilbridge 2010) between PBT and IMRT, if the protocol primary endpoint is met;
• To assess the pathologic response rate between PBT and IMRT;
• To assess the cost-benefit economic analysis of treatment between radiation modalities;
• To compare the length of hospitalization after protocol surgery between PBT and IMRT;
• To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT;
• To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT & IMRT;
• To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT;
• To compare incidence of both early (< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT;
• To compare the Total Toxicity Burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities.

Exploratory Objectives:

• To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications.

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 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 Objective:

• To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma.

Secondary Objectives:

• To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms
• To evaluate safety and tolerability associated with treatment in each of the treatment arms
• To evaluate the proportion of patients receiving second line of therapy in both arms
• To evaluate tolerability of the treatment in both arms using PRO-CTCAE

Module A Monotherapy—dose escalation

Primary Objective:

• To investigate the safety and tolerability of EP0031 given as monotherapy

Secondary Objective:

• To characterize the PK of EP0031 given as monotherapy, after a single dose and at steady state after multiple dosing

Modules B and C Monotherapy—dose expansion

Primary Objective:

• To assess the efficacy of EP0031 given as monotherapy in patients with RET-altered tumours who have progressed following firstgeneration SRI therapy and in patients with RET-altered tumors with no prior SRI therapy (by RECIST v1.1)

Secondary Objectives:

• To investigate the safety and tolerability of EP0031 given as monotherapy
• To characterize the PK of EP0031 given as monotherapy