Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

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Results 1 - 10 of 53

Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations
Objective:

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.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
S2001
Age Group:
Adult
Phase:
Phase II
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Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)
Objective:

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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Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
S2012
Age Group:
Adult
Phase:
Phase II/III
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A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
Objective:

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
Cancer Categories:
Breast,Gastrointestinal (GI),Head and Neck,Lung
Principal Investigator:
Assad, Hadeel
Karmanos Trial ID:
2023-100
Age Group:
Adult
Phase:
Phase I
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A Phase II, Open-Label, Multicohort, Multicenter Study in Patients with Unresectable Hepatocellular Carcinoma and Child-Pugh B Cirrhosis
Objective:

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
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2023-105
Age Group:
Adult
Phase:
Phase II
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A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)
Objective:

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.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
EA2182
Age Group:
Adult
Phase:
Phase II
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A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients
Objective:

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.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
EA2176
Age Group:
Adult
Phase:
Phase III
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An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic Solid Tumors
Objective:

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
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
Principal Investigator:
Hadid, Tarik
Karmanos Trial ID:
2023-090
Age Group:
Adult
Phase:
Phase I/II
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An Open-Label Study of GV20-0251 in Patients with Advanced and/or Refractory Solid Tumor Malignancies
Objective:

Part A

Primary Objectives:

To characterize the safety and tolerability of GV20-0251 and establish the MTD and/or the RP2D of GV20-0251

Secondary Objectives:

To characterize the PK of GV20-0251

To characterize the immunogenicity of antiGV20-0251 ADA and nADA

To evaluate the preliminary anti-tumor activity of GV20-0251

Part B

Primary Objectives:

To evaluate the ORR per RECIST version 1.1 of GV20-0251 in different tumor types

Secondary Objectives:

To characterize the safety of GV20-0251

To characterize the PK of GV20-0251

To characterize the immunogenicity of GV20-0251

To evaluate the anti-tumor activity of GV20-0251
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2023-106
Age Group:
Adult
Phase:
Phase I
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Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer
Objective:

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
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
NRG-GI004
Age Group:
Adult
Phase:
Phase III
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Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) For the Treatment of Esophageal Cancer
Objective:

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.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Hyde, Christian
Karmanos Trial ID:
NRG-GI006
Age Group:
Adult
Phase:
Phase III
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