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 187

  • 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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  • 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 Study)

    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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  • 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 Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

    Objective:
    Primary Objectives
    1. 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.
    2. If the stated threshold is met in both arms, to choose the better regimen with respect to PFS.

    Secondary Objectives
    1. 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.
    2. To assess overall survival (OS) in patients treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.
    3. 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 Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophosectomy to Reduce the Risk of Ovarian Cancer among BRCA1 Carriers [SOROCk]

    Objective:
    Primary Objective
    To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

    Secondary Objectives
    • To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.
    • To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
    • To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
    • To assess adverse events, graded using CTCAE v5.0.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • NRG-CC008
    Age Group:
    • Adult
    Phase:
    • NA
    Learn More

  • 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 Objectives:

    • 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 Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score RS) of 25 or Less

    Objective:

    Primary Objective:

    • To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Flaherty, Lawrence
    Karmanos Trial ID:
    • S1007
    Age Group:
    • Adult
    Phase:
    • Phase III
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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
    Learn More