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 196

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Objective:
Primary Objective:

To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).

Secondary Objectives:

To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.

To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.

To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.

To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.

To compare patient-reported symptoms using selected PRO-CTCAE items between arms stratified by age groups.

To compare the safety and tolerability of N-AVD versus that of BV-AVD.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Sano, Dahlia
Karmanos Trial ID:
S1826
Age Group:
Both
Phase:
Phase III
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Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Objective:

Primary Objectives

To evaluate whether progression-free survival (PFS) meets an efficacy threshold in patients with previously treated advanced small bowel adenocarcinoma who receive treatment with ramucirumab and paclitaxel or FOLFIRI.

If the stated threshold is met in both arms, to choose the better regimen with respect to PFS.

Secondary Objectives

To assess overall response rate (ORR) [complete and partial, confirmed and unconfirmed] in the subset of patients with measurable disease treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.

To assess overall survival (OS) in patients treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.

To evaluate safety and toxicity associated with combination ramucirumab and paclitaxel treatment or FOLFIRI therapy in this patient population.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
S1922
Age Group:
Adult
Phase:
Phase II
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A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer
Objective:

Primary
To compare the 3-year recurrence-free survival of women with high intermediate risk (HIR) Stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and MK-3475 (pembrolizumab) versus radiation alone.

Secondary Objectives

To describe the safety and tolerability of concurrent MK-3475 (pembrolizumab) and radiation compared to radiation alone in patients with MMR deficient high intermediate risk endometrial cancer (HIR EC).

To describe the recurrence patterns in each group.

To measure recurrence free survival at 5 years in each group.

To estimate disease specific overall survival in each group.

To determine whether the addition of MK-3475 (pembrolizumab) to radiation, compared with radiation alone is associated with decreased quality of life at 6- and 24-weeks, as measured with the FACT-En TOI, increased GI symptoms as measured with the GI subscale, and increased fatigue as measured with the PROMIS-Fatigue scale (short form).

To validate the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) subscale, which assesses in cancer patients on immunotherapy.
Cancer Categories:
Gynecologic
Principal Investigator:
Gogoi, Radhika
Karmanos Trial ID:
NRG-GY020
Age Group:
Adult
Phase:
Phase III
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A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persi
Objective:

Primary Objective

To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.

Secondary Objectives

1.2.1 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single-agent cediranib as measured by overall survival (OS) in patients with recurrent, persistent or metastatic endometrial cancer.

1.2.2 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment versus single-agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.

1.2.3 To assess the safety and tolerability of single–agent cediranib, single-agent olaparib, and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment).

1. 2.4 To assess if mutations in DNA Homologous Repair Genes (assayed prior to all treatment and prior to the study treatment) are predictive of response to olaparib alone or in combination with cediranib. (Integrated Biomarker)

1.2.5 To assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib. (Integrated Biomarker)
Cancer Categories:
Gynecologic
Principal Investigator:
Gogoi, Radhika
Karmanos Trial ID:
NRG-GY012
Age Group:
Adult
Phase:
Phase II
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A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Objective:
Primary Objective:
Phase II

To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).

Phase III

To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin).

Secondary Objectives:

To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm;

To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm;

To determine acute and late toxicity profiles as measured by the CTCAE;

To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE;

To compare changes in patient-reported outcomes (HHIA-S, EORTC-QLQ30) between each experimental arm and the control arm;

To assess the association of FDG-PET/CT at baseline with locoregional control and PFS;

To estimate the negative predictive value of the 12-14 weeks post-RT FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
NRG-HN005
Age Group:
Adult
Phase:
Phase II/III
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Objective:
Primary Objective:

To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Secondary Objectives:

To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.

To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.

To compare overall survival for each treatment arm.

To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.
Cancer Categories:
Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
NRG-GY019
Age Group:
Adult
Phase:
Phase III
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Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin
Objective:

Primary Objective

Evaluate the success of targeting a carboplatin AUC with our current approach to dosing carboplatin.

Assess the performance of CG, MDRD-4, and CKPD-EPI based on IDMS calibrated serum creatinine in predicting mGFR in patients with cancer.

Define the relationship of mGFR and carboplatin clearance in patients with cancer.

Secondary Objectives

Evaluate the divergence of eGFR from mGFR based on patient demographic and other characteristics, thus identifying those most likely to benefit from determination of mGFR over use of eGFR.

Determine the success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped.

Evaluate the relationship between carboplatin exposure and toxicity.

Assess the ability of markers other than creatinine in pretreatment serum to better estimate kidney function in patients with cancer.
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-GY022
Age Group:
Adult
Phase:
NA
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Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Objective:

Primary:

To determine whether SBRT can be shown to be superior to hypofractionated IMRT in terms of GU and GI toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel HRQOL as measured by EPIC-26 at 24 months post completion of therapy.

To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy) as measured by Disease Free Survival (DFS)

Secondary:

Secondary ObjectivesTo determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26
To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases
To determine the correspondence between the diagnostic MRI and biopsy
Cancer Categories:
Genitourinary (GU)
Principal Investigator:
Johnson, Matthew
Karmanos Trial ID:
NRG-GU005
Age Group:
Adult
Phase:
Phase III
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Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer
Objective:
Primary Objective:

To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC).

Secondary Objectives:

To compare overall survival between the two arms.

To compare modified bladder intact event-free survival (mBI-EFS see Section 10) including cancer related death between arms.

To compare complete and partial pathologic response between arms at 3 months after completing chemoradiation therapy.

To estimate metastases-free survival by arm.

To compare the qualitative and quantitative adverse events from each arm.

To estimate the rate of non-muscle invasive bladder cancer recurrence by arm.

To estimate the rate of salvage cystectomy and reasons for cystectomy by arm.

To compare mean patient-reported global quality of life (QOL) at week 54 using the EORTC QLQ-C30 Global Health Status (GHS) subscale score between patients with localized muscle-invasive bladder cancer randomized to chemoradiation with vs. without atezolizumab.
Cancer Categories:
Genitourinary (GU)
Principal Investigator:
Vaishampayan, Nitin
Karmanos Trial ID:
S1806
Age Group:
Adult
Phase:
Phase III
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Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Stud
Objective:
Primary Objective:

To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.

Secondary Objectives of First Randomization:

To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare progression-free survival (PFS) between the study arms in this patient population.

To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare toxicities and tolerability of long term therapy between the study arms.

Objectives of Second Randomization:

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S1803
Age Group:
Adult
Phase:
Phase III
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