Select Clinical Trials Currently Enrolling Patients with Colorectal Cancer

April 2018, Vol 8, No 4 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with different types of colorectal cancer for inclusion in investigations of new therapies as well as new regimens of existing treatments for patients with colorectal cancer. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncologists and other oncology practice providers direct eligible patients to an appropriate clinical trial.

1 Entrectinib for Solid Tumors with Certain Gene Rearrangements

This parallel-assignment, open-label, phase 2 clinical trial examines the use of the investigational drug entrectinib in patients with colorectal cancer (CRC) and NTRK1/2/3, ROS1, or ALK gene rearrangements.

Patients aged ≥18 years with a histologically or cytologically confirmed, locally advanced or metastatic solid tumor with NTRK1/2/3, ROS1, or ALK gene rearrangements and an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 may be eligible for enrollment if other criteria are met. Participants will receive entrectinib therapy. The primary outcome measure is the objective response rate (ORR) at approximately 24 months. The secondary outcome measures include overall survival (OS), progression-free survival (PFS), duration of response, and clinical benefit rate.

This study plans to enroll 300 patients at multiple locations across the United States and abroad. For more information, call 844-782-7875 or e-mail startrktrials@ignyta.com. The NLM Identifier is NCT02568267.

2 Chemotherapy plus Bevacizumab with/without Atezolizumab as First-Line Treatment for dMMR Metastatic CRC

The purpose of this randomized, parallel-assignment, open-label, phase 3 clinical trial is to determine the efficacy of using combination chemotherapy plus bevacizumab (Avastin) with or without atezolizu­mab (Tecentriq) for the treatment of patients with mismatch repair–deficient (dMMR) metastatic CRC.

Patients aged ≥18 years with metastatic dMMR cancer of the colon or rectum who have not received chemotherapy or any other systemic therapy for metastatic CRC and who have an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive combination chemotherapy plus bevacizumab with or without atezolizumab. The primary outcome measure is PFS. The secondary outcome measures include OS, ORR, disease control rate, duration of overal response, and surgical conversion.

This study expects to enroll 347 patients at multiple locations across the United States. For more information, call James J. Lee at 412-647-8073. The NLM Identifier is NCT02997228.

3 Fluorouracil plus CPI-613 for Previously Treated, Unresectable Metastatic CRC

This single-group assignment, open-label, phase 1 clinical trial is evaluating the side effects and optimal dose of CPI-613 administered concomitantly with fluorouracil for the treatment of patients with unresectable metastatic CRC.

Patients aged ≥18 years with histologically and cytologically confirmed, unresectable metastatic colon, rectal, or CRC and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive CPI-613 administered concomitantly with fluorouracil. The primary outcome measure is the maximum tolerated dose of CPI-613 plus fluorouracil, as determined by any dose-limiting toxicities. The secondary outcome measures include ORR, PFS, and incidence of toxicity.

This study expects to enroll 40 patients at the Comprehensive Cancer Center of Wake Forest University, Winston-Salem, NC. For more information, contact Rodwige Desnoyers at 336-713-6912 or rdesnoye@wakehealth.edu. The NLM Identifier is NCT02232152.

4 Trastuzumab plus Pertuzumab versus Cetuximab plus Irinotecan for Unresectable, Metastatic HER2-Amplified CRC

The purpose of this open-label, randomized, parallel-assignment, phase 2 clinical trial is to compare the efficacy of trastuzumab (Herceptin) plus pertuzumab (Perjeta) with that of cetuximab (Erbitux) plus irinotecan hydrochloride (Camp­­tosar) in the treatment of patients with unresectable, metastatic HER2-­amplified CRC.

Patients aged ≥18 years with histologically or cytologically confirmed metastatic or locally advanced, unresectable cancer of the colon or rectum and a Zubrod (ie, ECOG) performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive trastuzumab plus pertuzumab or cetuximab plus irinotecan hydrochloride.

The primary outcome measure is the efficacy of trastuzumab plus pertuzumab, determined by comparing the PFS rate of patients receiving trastuzumab plus pertuzumab with that of those receiving cetuximab plus irinotecan hydrochloride. The secondary outcome measures are ORR and OS. This study plans to enroll 130 patients at multiple locations across the United States. For more information, contact Danae Campos at 210-614-8808 (ext. 1022) or dcampos@swog.org, or Dana Sparks at 210-614-8808 (ext. 1004) or dsparks@swog.org. The NLM Identifier is NCT03365882.

5 Chemotherapy with/without Atezolizumab for Stage III dMMR Colon Cancer

This randomized, parallel-assignment, open-label, phase 3 clinical trial is comparing the use of combination chemotherapy plus atezolizumab with combination chemotherapy alone for the treatment of patients with stage III dMMR colon cancer. Patients aged ≥18 years with histologically confirmed stage III colon cancer and an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. Participants will receive combination chemotherapy with or without atezolizumab.

The primary outcome measure is disease-free survival. The secondary outcome measures are OS and the incidence of adverse events. This study plans to enroll 700 patients at multiple locations across the United States and abroad. For more information, call Frank A. Sinicrope at 855-776-0015. The NLM Identifier is NCT02912559.

6 Durvalumab plus Tremelimumab with/without Radiation Therapy for Metastatic CRC

This randomized, open-label, parallel-assignment, phase 2 clinical trial will evaluate the side effects of durvalumab (Imfinzi) plus tremelimumab, and how well they work with or without high- or low-dose radiation therapy for the treatment of patients with metastatic CRC. Patients aged ≥18 years with histologically or cytologically confirmed CRC and an ECOG performance status ≤1 may be eligible for enrollment if other criteria are met. Participants will receive durvalumab plus tremelimumab, with or without high- or low-dose radiation therapy.

The primary outcome measure is the ORR. The secondary outcome measures include PFS, OS, and the incidence of adverse events. This study expects to enroll 180 patients at multiple locations across the United States and abroad. For more information, call Jonathan D. Schoenfeld at 877-726-5130. The NLM Identifier is NCT02888743.

7 FOLFIRI with/without Napabucasin for Adults with Metastatic CRC

This multicenter, open-label, randomized, phase 3 clinical trial will assess the use of biweekly 5-fluorouracil, leucovorin, and irinote­can (FOLFIRI), with or without the investigational drug napabucasin, for the treatment of patients with metastatic CRC that progressed after previous treatment. Patients aged ≥18 years with histologically confirmed, advanced or metastatic CRC who did not respond to treatment containing fluoropyrimidine and oxaliplatin (with or without bevacizumab) whose ECOG performance status is 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive the FOLFIRI regimen, with or without napabucasin.

The primary outcome measure is OS. The secondary outcome measures are PFS, ORR, quality of life, disease control rate, and the number of patients with adverse events. This study expects to enroll 1250 patients at multiple locations across the United States and abroad. For more information, contact Boston Biomedical at 617-674-6800. The NLM Identifier is NCT02753127.

8 Capecitabine and Bevacizumab with/without Atezolizumab for Refractory Metastatic CRC

The purpose of this randomized, parallel-assignment, phase 2 clinical trial is to evaluate the efficacy of atezolizumab and capecitabine (Xeloda) with or without bevacizumab for the treatment of patients with refractory metastatic CRC. Patients aged ≥18 years with histologically confirmed metastatic CRC that progressed with fluoropyrimidine-, oxaliplatin-, irinotecan-, and bevacizu­­mab-containing regimens, and who have an ECOG performance status 0 to 1 may be eligible for enrollment if other criteria are met. Participants will receive bevacizu­mab and capecitabine, with placebo or with atezolizumab.

The primary outcome measure is PFS. The secondary outcome measures are OS and ORR. This study expects to enroll 135 patients at multiple locations across the United States. For more information, contact Ireka Burrus at 919-668-1861 or ireka.burrus@duke.edu. The NLM Identifier is NCT02873195.

9 Cabozantinib plus Panitumumab for KRAS Wild-Type Metastatic CRC

The purpose of this nonrandomized, open-label, parallel-assignment, phase 1 clinical trial is to evaluate the use of cabozantinib (Cometriq) plus panitumumab (Vectibix) in patients with KRAS wild-type metastatic CRC, and the use of cabozantinib monotherapy in patients with refractory, MET-amplified CRC. Patients aged ≥18 years with histologically or cytologically confirmed metastatic and/or unresectable KRAS wild-type cancer of the colon or rectum who received previous treatment with fluoropyrimidine, oxaliplatin, irinotecan, and bevacizu­mab or have a contraindication to such treatment, and who have an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive cabozantinib with or without panitumumab.

The primary outcome measures are the recommended phase 2 dose of cabozantinib plus panitumumab, and the ORR of cabozantinib monotherapy. The secondary outcome measures include PFS, OS, and the non–dose-limiting toxicities of cabozantinib and panitumumab. This study expects to enroll 50 patients at the Duke Cancer Center, Duke University Medical Center, Durham, NC. For more information, contact Christy Arrowood at 919-668-1861 or christy.arrowood@duke.edu, or Anthony Amara, MSW, at 919-668-1861 or anthony.amara@duke.edu. The NLM Identifier is NCT02008383.

10 Nivolumab Alone or with Other Oncolytics for Recurrent or Metastatic CRC with Microsatellite Instability

This nonrandomized, parallel-assignment, open-label, phase 2 clinical trial will determine whether nivolumab (Opdivo) used as monotherapy or in combination with other anticancer drugs can reduce tumor size in patients with recurring or metastasized CRC associated with high microsatellite instability (MSI-H) or non–MSI-H.

Patients aged ≥18 years with histologically confirmed recurrent or metastatic CRC who have been tested by an accredited lab for their MSI status and their ECOG performance status is 0 to 1 may be eligible for enrollment if other criteria are met. Participants will receive nivolumab alone or in combination with other anticancer drugs.

The primary outcome measure is ORR. The secondary outcome measure is ORR determined by an independent review committee. This study expects to enroll 340 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02060188.

11 eFT508 with/without Avelumab for Micro­satellite Stable Relapsed or Refractory CRC

The purpose of this randomized, open-label, parallel-assignment, phase 2 clinical trial is to determine the maximum tolerated dose of eFT508 that can be used in combination with avelumab (Bavencio) for the treatment of patients with microsatellite stable relapsed or refractory CRC, and to assess the antitumor activity of eFT508 as monotherapy or in combination with avelumab. Patients aged ≥18 years with pathologically confirmed, relapsed or refractory, microsatellite stable CRC; adequate bone marrow, hepatic, and renal functions; and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive eFT508 with or without avelumab.

The primary outcome measures are dose-limiting toxicity during the first treatment cycle and ORR. This study plans to enroll 70 patients at multiple centers across the United States. For more information, contact Cara Casseday, BSc, MBA, at 619-990-8136 or ccasseday@effector.com, or Debra Vallner, PhD, MBA, at 650-619-0015 or dvallner@effector.com. The NLM Identifier is NCT03258398.

12 Tucatinib plus Trastuzumab for HER2-­Positive Metastatic CRC

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to evaluate the efficacy of combining the investigational drug tucatinib with trastuzumab (Herceptin) for the treatment of patients with HER2-positive metastatic CRC. Patients aged ≥18 years with metastatic and/or unresectable cancer of the colon or rectum who received previous treatment with fluoropyrimidine, oxaliplatin (Eloxatin), irinotecan, and bevacizumab or have contraindication to such treatment, and who have an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive tucatinib and trastuzumab.

The primary outcome measure is ORR, defined as a complete or ­partial response. The secondary outcome measures are clinical best response, duration of response, incidence of grade ≥2 adverse events, OS, and PFS. This study expects to enroll 25 patients at multiple centers across the United States. For more information, contact Ireka Burrus at 919-668-1861 or ireka.burrus@duke.edu. The NLM Identifier is NCT03043313.

13 MGD007 for Patients with Relapsed or Refractory Metastatic CRC

This nonrandomized, open-label, parallel-assignment, phase 1 clinical trial assesses the safety and tolerability of using MGD007, a humanized glycoprotein A33 × CD3 dual-affinity retargeting protein, for the treatment of patients with metastatic CRC, and will determine the administration schedule and maximum tolerated dose of MGD007 for this patient population. Patients aged ≥18 years with untreated, histologically confirmed, refractory, metastatic CRC and an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive varying doses of MGD007.

The primary outcome measure is dose-limiting toxicity, which will be used to determine a maximum tolerated dose and administration schedule. The secondary outcome measures are evidence of antitumor activity, and the pharmacokinetics and immunogenicity of MGD007. This study expects to enroll 103 patients at multiple centers across the United States. For more information, contact Joanna Lohr at 240-552-8030 or lohrj@­macrogenics.com, or Susan Brann at 240-552-8023 or branns@macrogenics.com. The NLM Identifier is NCT02248805.

14 Lamivudine for Patients with Metastatic CRC and TP53 Mutation or Deletion

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to evaluate the safety and efficacy of lamivudine (Combivir) for the treatment of patients with metastatic CRC and the p53 protein, manifesting as a TP53 mutation or deletion. Patients aged ≥18 years with histologically confirmed stage IV metastatic CRC with TP53 mutation or deletion, an ECOG performance status ≤2, and life expectancy of >8 weeks may be eligible for enrollment if other criteria are met. Participants will receive lamivudine.

The primary outcome measure is ORR. The secondary outcome measures are PFS, OS, and overall disease control rate. This study expects to enroll 32 patients at Massachusetts General Hospital, Boston. For more information, contact Aparna R. Parikh, MD, at 617-724-4000 or Aparna.Parikh@mgh.harvard.edu. The NLM Identifier is NCT03144804.