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 49

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed By Concurrent Mediastinal Chemoradiation For Locally Advanced Non-Small Cell Lung Cancer
Objective:

Primary Objectives:

To compare the overall survival in patients with stage II-IIIC inoperable nodepositive
non-small cell lung cancer (NSCLC) after image guided, motion-managed
conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after
image guided, motion-managed stereotactic body radiation therapy (SBRT) to the
primary tumor followed by conventionally fractionated radiotherapy to nodal
metastases (Arm 2) both given with concurrent platinum-based chemotherapy.

To compare progression-free survival between the experimental arm (Arm 2) and
control arm (Arm 1).

Secondary Objectives:

To compare objective response rate (as defined by RECIST v 1.1) between the
experimental arm and control arm

To compare the rate of local control between the experimental arm and control arm

To compare patterns of failure (primary, locoregional, or distant) between the
experimental arm and control arm

To compare changes in pulmonary function (FEV1 and DLCO assessed at
randomization and at 6 and 12 months following completion of radiation therapy)
between the experimental arm and control arm

To compare changes in quality of life and patient-reported outcomes assessed from
pre-treatment to 3 months following radiation therapy of each treatment arm

To determine acute and late toxicity profiles of each treatment arm as measured by
the CTCAEv5
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU008
Age Group:
Adult
Phase:
Phase III
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PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Objective:

Primary Objective:

To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.

Secondary Objective:

To summarize reports of serious and unexpected high-grade (≥ Grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
Cancer Categories:
Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
S2302
Age Group:
Adult
Phase:
Phase II
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Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Objective:

Primary Objective

Phase II:

To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:

To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives

To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm

To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors

To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU007
Age Group:
Adult
Phase:
Phase II/III
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A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and with Combination Therapies in Patients with Solid Tumors
Objective:

Phase 1a (Dose Escalation)

Primary Objectives:

To assess the safety and tolerability of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) in patients with solid tumors

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended doses for expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

Secondary Objectives:

To assess the preliminary antitumor activity of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

To characterize the pharmacokinetic (PK) profile of BGB-24714 and its major metabolite BGB-22437 following the administration of capsules as monotherapy, in combination with chemotherapy, and in combination with cCRT

Phase 1b (Dose Expansion)

Primary Objectives:

To assess the preliminary antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

Secondary Objectives:

To further evaluate the secondary measures of antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

To further characterize the safety and tolerability of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

To further characterize the PK profile of BGB-24714 and its major metabolite in combination with chemotherapy in patients with selected solid tumors
Cancer Categories:
Gynecologic,Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-057
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects with Advanced Solid Tumors
Objective:

Primary Objectives:

To determine the safety and tolerability of OBI-992 when administered intravenously (IV) to subjects with advanced solid tumors

To determine the maximum tolerated dose (MTD) and optimal recommended Phase 2 dose (RP2D) of OBI-992 using randomized assignment to 2 dose level cohorts and assessment of activity, safety, and tolerability for each cohort

To evaluate the preliminary clinical activity profile of OBI-992 (objective response rate [ORR], clinical benefit rate [CBR], duration of response [DOR], disease control rate [DCR], and progression-free survival [PFS])

Secondary Objectives:

To determine the serum pharmacokinetics (PK) of OBI-992 and its active metabolite exatecan

To evaluate the immunogenicity of OBI992 (anti-drug antibodies [ADAs])
Cancer Categories:
Gastrointestinal (GI),Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-037
Age Group:
Adult
Phase:
Phase I/II
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An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer
Objective:

Primary Objective:

To characterize the safety and tolerability of different dose levels of ZL-1310, including dose‑limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RD).

Secondary Objectives:

To assess the preliminary efficacy of ZL-1310.

To characterize the pharmacokinetics (PK) of ZL-1310 as a single agent, after a single dose and multiple doses.
Cancer Categories:
Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2024-024
Age Group:
Adult
Phase:
Phase I
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An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination with Pembrolizumab in Subjects with Locally Advanced or Metastatic Solid Tumors
Objective:

Primary Objectives

To assess the safety and tolerability and determine the maximum-tolerated dose (MTD) and/or the RP2D of INBRX-106 as a single agent administered as an IV infusion in adult subjects with locally advanced or metastatic solid tumors.

To assess the safety and tolerability and determine the MTD and/or the RP2D of INBRX-106 in combination with pembrolizumab administered as an IV infusion in adult subjects with locally advanced or metastatic solid tumors.

To assess the safety and tolerability of INBRX-106 in combination with pembrolizumab and chemotherapy regimens in adult subjects with locally advanced or metastatic NSCLC.

To assess the antitumor activity of INBRX-106 in combination with pembrolizumab. (Part 4 Cohorts F3 and F4)

Secondary Objectives

To assess the PK of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy.

To assess the immunogenicity of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy.

To assess the preliminary antitumor activity of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy. (All cohorts except F3 and F4)
Cancer Categories:
Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2024-043
Age Group:
Adult
Phase:
Phase I/II
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Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing
Objective:

Primary Objective:

To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

Secondary Objectives:

To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin

To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin

To evaluate toxicities of PORT alone or PORT with concurrent cisplatin.

To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.

To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.
Cancer Categories:
Head and Neck,Lung
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
EA3132
Age Group:
Adult
Phase:
Phase II
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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
Objective:

Primary Objectives:

To investigate the safety of monotherapy and T- Plex combination TCR-Ts

To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Secondary Objectives:

To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts

To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
Cancer Categories:
Gynecologic,Hematologic (Blood Cancers),Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2023-086
Age Group:
Adult
Phase:
Phase I
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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
Learn More

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