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.

Request an Appointment Refer a Patient NCI Dictionary of Cancer Terms Clinical Trials App

Hide Search Criteria

Cancer Category

Enter Keyword

Clinical Trial Phase

Therapies Involved

Device Involved

Study Site

NCT ID

KCI Trial ID

Drug Involved

Principal Investigator

Clear Search

Results 1 - 10 of 55

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer
Objective:

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).
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-GY031
Age Group:
Adult
Phase:
Phase I
Learn More
A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator's Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Objective:

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
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3097
Age Group:
Adult
Phase:
Phase III
Learn More
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
Learn More
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
Learn More
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
/ul>
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
S2012
Age Group:
Adult
Phase:
Phase II/III
Learn More
Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma
Objective:

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
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
A022102
Age Group:
Adult
Phase:
Phase III
Learn More
A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors
Objective:

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
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2024-025
Age Group:
Adult
Phase:
Phase I/II
Learn More
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
Learn More
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb®541 in Advanced Solid Tumors
Objective:

Primary Objectives:

To assess the safety and tolerability of study drug

To identify the recommended dose(s) (RD[s]) and schedule(s) that is (are) safe and biologically effective for study drug administered by intravenous (IV) dosing

To identify the RD(s) and schedule(s) that is (are) safe and biologically effective for study drug administered by subcutaneous (SC) dosing

Secondary Objectives:

To characterize the pharmacokinetics (PK) of study drug administered by IV dosing

To characterize the PK of study drug administered by SC dosing

To assess the preliminary antitumor activity of study drug
Cancer Categories:
Gastrointestinal (GI),Gynecologic,Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-013
Age Group:
Adult
Phase:
Phase I
Learn More
A Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma.
Objective:

Phase 1 (Dose-escalation and Dose-expansion)

Primary Objectives:

Part A: Dose-escalation:

To characterize the safety and tolerability of LB1908 and determine the optimal dose or recommended dose for expansion (RDE)

Part B: Dose-expansion:

To further characterize the safety and tolerability of LB1908 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D)

Secondary Objectives (Parts A and B):

To evaluate the preliminary efficacy of LB1908

To characterize the pharmacokinetics of LB1908 in blood

To evaluate the immunogenicity of LB1908
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2024-005
Age Group:
Adult
Phase:
Phase I
Learn More

1 2 3 4 5 6