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QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03563157
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : May 17, 2019
Information provided by (Responsible Party):
NantKwest, Inc.

Brief Summary:
QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: Phase 1b/2 NANT CRC Vaccine vs Regorafenib in Subjects with CRC Who have Previously Treated with SOC.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic mCRC Biological: Aldoxorubicin Hydrochloride Biological: ALT-803 Biological: ETBX-011 Biological: ETBX-021 Biological: ETBX-051 Biological: ETBX-061 Biological: GI-4000 Biological: GI-6207 Biological: GI-6301 Biological: haNK Drug: Avelumab Drug: Capecitabine Drug: Cetuximab Drug: Cyclophosphamide Drug: 5-Fluorouracil Drug: Leucovorin Drug: Nab-paclitaxel Drug: Oxaliplatin Drug: Regorafenib Procedure: SBRT Phase 1 Phase 2

Detailed Description:
NANT Colorectal Cancer (CRC) Vaccine: A phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects with Metastatic CRC Who Have Been Previously Treated with Standard-Of-Care Therapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: NANT Colorectal Cancer (CRC) Vaccine
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT.
Biological: Aldoxorubicin Hydrochloride
Aldoxorubicin Hydrochloride HCI

Biological: ALT-803
Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1]

Biological: ETBX-011
Ad5 [E1-, E2b-]-CEA

Biological: ETBX-021
Ad5 [E1-, E2b-]-[HER2]

Biological: ETBX-051
Ad5 [E1-, E2b-]-Brachyury

Biological: ETBX-061
Ad5 [E1-, E2b-]-mucin 1 [MUC1]

Biological: GI-4000
RAS yeast

Biological: GI-6207
CEA yeast

Biological: GI-6301
Brachyury yeast

Biological: haNK
haNK™, NK-92 [CD16.158V, ER IL-2]

Drug: Avelumab
BAVENCIO® injection

Drug: Capecitabine
XELODA® tablets

Drug: Cetuximab
ERBITUX® injection

Drug: Cyclophosphamide
Cyclophosphamide Capsules

Drug: 5-Fluorouracil
5-FU; Fluorouracil Injection

Drug: Leucovorin
Leucovorin Calcium

Drug: Nab-paclitaxel
ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound]

Drug: Oxaliplatin
ELOXATIN® injection

Drug: Regorafenib
STIVARGA® tablets

Procedure: SBRT
Stereotactic body radiation therapy

Active Comparator: Regorafenib
In subjects with metastatic CRC who have been previously treated with standard-of-care (SOC) therapy.
Drug: Regorafenib
STIVARGA® tablets

Primary Outcome Measures :
  1. Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03 [ Time Frame: 2 years ]
    Phase 1b

  2. Progression Free Survival from baseline to progression, per RECIST 1.1 [ Time Frame: 2 years ]
    Phase 2 Randomized Component

  3. Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete Response per RECIST 1.1 [ Time Frame: 1 year ]
    Phase 2 Single Arm Component

Secondary Outcome Measures :
  1. ORR for Phase 1b and Phase 2 Randomized Component [ Time Frame: 1 year ]
    Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1 and irRC

  2. PFS for Phase 1b and Phase 2 Single Arm Component [ Time Frame: 2 years ]
    Progression Free Survival from baseline to progression per RECIST 1.1 and irRC

  3. OS for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component [ Time Frame: 2 years ]
    Overall Survival from first treatment to date of death (any cause)

  4. DOR for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component [ Time Frame: 2 years ]
    Duration of Response from date of first response to date of disease progression or death (any cause), per RECIST 1.1 and irRC

  5. DCR for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component [ Time Frame: 1 year ]
    Disease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1 and irRC

  6. QoL for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component [ Time Frame: 2 years ]
    Quality of Life as assessed by Patient Reported Outcomes using the FACT-C questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  3. Histologically-confirmed recurrent or metastatic CRC previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy; or subjects who are ineligible for these therapies.
  4. ECOG performance status of 0 or 1.
  5. Have at least 1 measurable lesion of ≥ 1.0 cm.
  6. Must have a recent FFPE tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
  7. Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
  8. Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
  9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  10. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non- sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence.

    Phase 2 single-arm component only

  11. Must have progressed on or after regorafenib treatment in the randomized phase 2 portion of the study OR progressed or experienced unacceptable toxicity on SoC and regorafenib prior to enrollment on the study.

Exclusion Criteria:

  1. MSI-high or MMR-deficient tumors eligible for, but not yet treated with, a PD-1 inhibitor.
  2. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the subject at high risk for treatment-related complications.
  3. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
  4. History of organ transplant requiring immunosuppression.
  5. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  6. Inadequate organ function, evidenced by the following laboratory results:

    1. ANC < 1,000 cells/mm^3.
    2. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL)
    3. Platelet count < 75,000 cells/mm^3.
    4. Total bilirubin > ULN (unless the subject has documented Gilbert's syndrome).
    5. AST (SGOT) or ALT (SGPT) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
    6. ALP > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
    7. Serum creatinine > 2.0 mg/dL or 177 μmol/L.
    8. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
  7. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
  8. Serious myocardial dysfunction defined by ECHO as absolute LVEF 10% below the institution's lower limit of predicted normal.
  9. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  10. Positive results of screening test for HIV.
  11. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  12. Known hypersensitivity to any component of the study medication(s).
  13. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  14. Concurrent or prior use of a strong CYP3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  15. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  16. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
  17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  18. Concurrent participation in any interventional clinical trial.
  19. Pregnant and nursing women.

    Phase 2 randomized component only

  20. Prior regorafenib treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03563157

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United States, California
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245
Sponsors and Collaborators
NantKwest, Inc.
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Responsible Party: NantKwest, Inc. Identifier: NCT03563157    
Other Study ID Numbers: QUILT-3.071
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NantKwest, Inc.:
Colorectal Cancer
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents