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 I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With MEDI4736 (Durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)
Objective:

Primary Objective

To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe.

Secondary Objectives

To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible.

To assess toxicities associated with the addition of MEDI4736 (durvalumab) to radiation therapy.

To obtain preliminary estimates of progression-free survival (PFS), using RECIST guidelines, in patients who received MEDI4736 (durvalumab) added to radiation. Although the clinical benefit of MEDI4736 (durvalumab) in combination with radiotherapy has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response.
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU004
Age Group:
Adult
Phase:
Phase I
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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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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 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 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 Open-label, Dose-escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
Objective:

Primary Objective

The primary objectives for this study are:

Part A (LUNA18 monotherapy dose escalation cohorts), Part AA (LUNA18 monotherapy backfill cohorts) and Part D (LUNA18 combination dose finding cohorts):

To evaluate the safety and tolerability of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)

To determine the maximum tolerated dose (MTD) and the recommended dose (RD) when administered as a single agent (Part A) and in combination with other anti-cancer drugs (Part D)

To characterize the PK profile of LUNA18 in plasma when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)

Part B (LUNA18 monotherapy biomarker cohorts):

To evaluate the safety and tolerability of LUNA18

To evaluate the inhibition of the phosphorylation level of extracellular signal-regulated kinase (ERK) protein (pERK) and other biomarkers as applicable in tumor tissues

To evaluate the preliminary anti-tumor activity of LUNA18

Part C (LUNA18 monotherapy expansion cohorts) and Part E (LUNA18 combination expansion cohorts):

To evaluate the safety and tolerability of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

To evaluate the preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

Secondary Objectives

The secondary objectives for this study are:

Part A (LUNA18 monotherapy dose escalation cohorts), Part AA (LUNA18 monotherapy backfill cohorts) and Part D (LUNA18 combination dose finding cohorts):

To evaluate the preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)

To evaluate the immunogenicity of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)

To evaluate the inhibition of the phosphorylation level of pERK and other biomarkers as applicable in tumor tissues when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)

To evaluate the difference of LUNA18 PK between hard capsule and soft capsule (Part A, Part AA)

To evaluate the difference of LUNA18 PK between monotherapy (Part A, Part AA) and combination therapy (Part D)

To characterize PK profile and immunogenicity of other anti-cancer drugs when administered in combination with LUNA18 (Part D)

Part B (LUNA18 monotherapy biomarker cohorts):

To evaluate the additional preliminary anti-tumor activity of LUNA18

To characterize the PK profile and to evaluate the immunogenicity of LUNA18

Part C (LUNA18 monotherapy expansion cohorts) and Part E (LUNA18 combination expansion cohorts):

To evaluate the additional preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

To characterize PK profile and to evaluate the immunogenicity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

To evaluate the inhibition of the phosphorylation level of pERK and other biomarkers as applicable in tumor tissues when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

To characterize PK profile and immunogenicity of other anti-cancer drugs when administered in combination with LUNA18 (Part E)
Cancer Categories:
Gastrointestinal (GI),Lung
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2023-035
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
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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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