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 50

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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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 Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies
Objective:

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
Cancer Categories:
Gastrointestinal (GI),Head and Neck,Lung
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2023-066
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of SGN-EGFRd2

To identify the maximum tolerated dose (MTD) of SGN-EGFRd2 (Part A)

To identify a recommended dose and schedule for SGN-EGFRd2 (Parts A and B)

Secondary Objectives:

To assess the immunogenicity of SGN-EGFRd2

To assess the PK of SGN-EGFRd2

To assess the antitumor activity of SGN-EGFRd2
Cancer Categories:
Brain and Nervous System,Gastrointestinal (GI),Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2023-055
Age Group:
Adult
Phase:
Phase I
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A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants with Advanced Malignancies
Objective:

Dose Escalation

Primary Objective

To assess the safety and tolerability of AB598 in patients with advanced malignancies

Secondary Objectives

To describe the PK profile of AB598 in patients with advanced malignancies

To assess the immunogenicity to AB598 in patients with advanced malignancies

To assess the clinical activity of AB598 in participants with advanced malignancies

Dose Expansion

Primary Objective

To characterize the safety and tolerability of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies

Secondary Objectives

To characterize the PK profile of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies

To assess the immunogenicity to AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies

To assess the clinical activity of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2023-077
Age Group:
Adult
Phase:
Phase I
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A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2
Objective:

Primary Objective:

To evaluate the antitumor activity of disitamab vedotin in subjects with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors

Secondary Objectives:

To evaluate the safety and tolerability profile of disitamab vedotin

To assess other measures of antitumor activity of disitamab vedotin per investigator assessment by other clinically relevant measures

To evaluate the pharmacokinetics (PK) of disitamab vedotin

To evaluate the immunogenicity of disitamab vedotin
Cancer Categories:
Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2023-069
Age Group:
Adult
Phase:
Phase II
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A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies
Objective:

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.
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2023-081
Age Group:
Adult
Phase:
Phase I
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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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Clinical Trials Actively Recruiting

Dose Escalation

Primary Objective

Secondary Objectives

Dose Expansion

Primary Objective

Secondary Objectives