QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer

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Brief Title

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

Official Title

QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

Brief Summary

      This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies
      in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint
      inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1
      checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration.
      Some patients who experience disease progression while on study in Cohorts 1-4 may roll over
      into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N-803,
      and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks
      in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive
      the same checkpoint inhibitor that they received during their previous therapy. Radiologic
      evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2
      years, or until the patient experiences confirmed progressive disease or unacceptable
      toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's
      best interest to continue treatment. Patients will be followed for disease progression,
      post-therapies, and survival through 24 months past administration of the first dose of study
      drug.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate

Secondary Outcome

 Disease-specific Survival

Condition

Non-Small Cell Lung Cancer

Intervention

N-803 + Pembrolizumab

Study Arms / Comparison Groups

 Cohort 1
Description:  Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor.
1a - Non-small cell lung cancer
1b - Small cell lung cancer
1c - Urothelial carcinoma
1d - Head and neck squamous cell carcinoma
1e - Merkel cell carcinoma
1f - Melanoma
1g - Renal cell carcinoma
1h - Gastric cancer
1i - Cervical cancer
1j - Hepatocellular carcinoma
1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

145

Start Date

December 11, 2018

Completion Date

August 2021

Primary Completion Date

June 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Signed Written Informed Consent

             • Voluntary written informed consent and HIPAA authorization and agree to comply with
             all protocol-specified procedures and follow-up evaluations

          2. Target Population

               1. Cohort 1 will enroll patients who have Investigator-assessed disease progression
                  on or after single-agent checkpoint inhibitor therapy after experiencing an
                  initial response (ie, Investigator-assessed CR or PR) while taking checkpoint
                  inhibitor therapy. Patients will be enrolled into distinct cohorts (1a-1k) based
                  on cancer type.

                  Patients must have been treated with checkpoint inhibitor therapy after
                  progressing on SoC therapy for their disease, as per FDA indication detailed
                  below:

                    -  1a - For metastatic squamous or nonsquamous NSCLC with progression on or
                       after nivolumab, pembrolizumab, or atezolizumab, initial SoC therapy must
                       have been for disease with progression on or after one prior platinum
                       doublet-based chemotherapy regimen. Patients with EGFR or ALK genomic tumor
                       aberrations should have had disease progression on FDA-approved targeted
                       therapy for these aberrations prior to receiving checkpoint inhibitor.

                    -  1b - For metastatic SCLC with disease progression on or after nivolumab or
                       pembrolizumab monotherapy, initial SoC treatment must have been for disease
                       with progression after platinum-based chemotherapy and at least one other
                       line of therapy prior to receiving checkpoint.

                    -  1c - Locally advanced or metastatic urothelial carcinoma as follows:

                    -  For patients with progression on or after nivolumab monotherapy, initial SoC
                       must have been for disease with progression on or after platinum-based
                       chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with
                       platinum-based chemotherapy.

                    -  For patients with disease progression on or after pembrolizumab, initial SoC
                       therapy may have been for locally advanced or metastatic urothelial
                       carcinoma ineligible for cisplatin-containing chemotherapy with PD-L1 tumor
                       expression of CPS ≥ 10 (as determined by FDA-approved test), OR metastatic
                       urothelial carcinoma not eligible for any platinum-containing chemotherapy
                       regardless of PD-L1 status, OR locally advanced or metastatic urothelial
                       carcinoma with progression on or after platinum-based chemotherapy or within
                       12 months of neoadjuvant or adjuvant treatment with platinum-based
                       chemotherapy.

                    -  For patients with disease progression on or after atezolizumab, initial SoC
                       therapy may have been for locally advanced or metastatic urothelial
                       carcinoma not eligible for cisplatin-based chemotherapy that expresses PD-L1
                       (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the
                       tumor area, as determined by an FDA-approved test), OR not eligible for
                       cisplatin-based chemotherapy regardless of PD-L1 status, OR with progression
                       on or after platinum-based chemotherapy or within 12 months of neoadjuvant
                       or adjuvant treatment with platinum-based chemotherapy.

                    -  For patients with disease progression on or after avelumab, initial SoC
                       therapy may have been for locally advanced or metastatic urothelial
                       carcinoma with progression on or after platinum-based chemotherapy or within
                       12 months of neoadjuvant or adjuvant treatment with platinum-based
                       chemotherapy.

                    -  For patients with disease progression on or after durvalumab, initial SoC
                       therapy may have been for disease with progression on or after
                       platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant
                       treatment with platinum-based chemotherapy.

                    -  1d - Recurrent or metastatic HNSCC as follows:

                    -  For patients with disease progression on or after nivolumab monotherapy,
                       initial SoC treatment must have been for disease with progression on or
                       within 6 months of a platinum-based therapy administered in the adjuvant,
                       neoadjuvant, primary (unresectable locally advanced), or metastatic setting.

                    -  For patients with disease progression on or after pembrolizumab monotherapy,
                       initial SoC treatment must have been for disease with progression on or
                       after platinum-based chemotherapy, or after platinum-based chemotherapy
                       administered as part of induction, concurrent, or adjuvant therapy.

                    -  1e - For histologically confirmed metastatic MCC with progression on or
                       after avelumab or pembrolizumab, initial SoC therapy must have been for
                       disease with progression on or after chemotherapy administered for distant
                       metastatic disease; OR recurrent locally advanced or metastatic MCC not
                       treated with prior systemic therapy for advanced disease.

                    -  1f - Metastatic melanoma as follows:

                    -  For patients with disease progression on or after nivolumab administered as
                       a single agent, in combination with ipilimumab, or in the adjuvant setting,
                       initial SoC treatment must have been for unresectable or metastatic melanoma
                       with progression on or after ipilimumab treatment, and if BRAF V600 mutation
                       positive, a BRAF inhibitor; OR BRAF V600 wild-type unresectable or
                       metastatic melanoma previously untreated in the metastatic setting; OR
                       previously untreated, unresectable, or metastatic melanoma not previously
                       treated with anti-CTLA4 antibody; OR completely resected melanoma with lymph
                       node involvement, or stage IIIB/C or stage IV metastatic disease.

                    -  For patients with disease progression on or after pembrolizumab therapy,
                       initial SoC treatment must have been for unresectable or metastatic melanoma
                       with no prior ipilimumab, and no more than 1 prior systemic treatment for
                       metastatic disease. Patients with BRAF V600E mutation-positive melanoma were
                       not required to have received prior BRAF inhibitor therapy; OR unresectable
                       or metastatic melanoma with progression, refractory to ≥ 2 doses of
                       ipilimumab (3 mg/kg or higher) and, if BRAF V600 mutation-positive, a BRAF
                       or MEK inhibitor, and disease progression within 24 weeks following the last
                       dose of ipilimumab.

                    -  1g - For advanced RCC with progression on or after nivolumab monotherapy,
                       initial SoC therapy must have been for disease that progressed after 1 or 2
                       prior anti-angiogenic therapy regimens. For intermediate or poor risk
                       previously untreated advanced RCC, patients must have progressed on or after
                       nivolumab + ipilimumab.

                    -  1h - For recurrent locally advanced or metastatic gastric or
                       gastroesophageal junction adenocarcinoma with progression on or after
                       pembrolizumab, initial SoC therapy must have been for disease that
                       progressed on or after ≥ 2 prior lines of therapy including
                       fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate,
                       HER2/neu-targeted therapy. Tumors must express PD-L1 (combined positive
                       score [CPS] ≥ 1), as determined by an FDA-approved test.

                    -  1i - For recurrent or metastatic cervical cancer with progression on or
                       after pembrolizumab, initial SoC therapy must have been for disease that
                       progressed on or after chemotherapy. Tumors must express PD-L1 (CPS ≥ 1), as
                       determined by an FDA-approved test.

                    -  1j - For HCC with progression on or after pembrolizumab, initial SoC
                       treatment must have been for disease that progressed on or after sorafenib
                       or intolerant to sorafenib. Patients must have had measureable disease and
                       Child-Pugh class A liver impairment. For HCC with progression on or after
                       nivolumab administered as a single agent or in combination with ipilimumab,
                       initial SoC treatment must have been for histologically confirmed HCC with
                       progression on sorafenib or intolerant to sorafenib, and Child-Pugh class A.

                    -  1k -Unresectable or metastatic MSI-H or dMMR solid tumors as follows:

                    -  For patients with progression on or after nivolumab administered as a single
                       agent or in combination with ipilimumab, initial SoC therapy must have been
                       for MSI-H or dMMR metastatic CRC with progression on or after treatment with
                       a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

                    -  For patients with progression on or after pembrolizumab, initial SoC therapy
                       must have been for unresectable or metastatic MSI-H or dMMR solid tumors
                       with progression after prior treatment and no satisfactory alternative
                       treatment options; OR unresectable or metastatic MSI-H or dMMR CRC with
                       progression after treatment with a fluoropyrimidine, oxaliplatin, and
                       irinotecan.

               2. For cohort 2, patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥
                  50%) and who have Investigator-assessed disease progression on a PD-1/PD-L1
                  checkpoint inhibitor after experiencing an initial Investigator-assessed CR or PR
                  when they received checkpoint inhibitor as a single-agent for first-line
                  treatment.

               3. For cohort 3, patients with NSCLC who had an initial Investigator-assessed CR or
                  PR but subsequently relapsed (ie, Investigator-assessed disease progression) on
                  maintenance PD-1/PD-L1 checkpoint inhibitor therapy when they initially received
                  checkpoint inhibitor therapy in combination with chemotherapy as first-line
                  treatment.

               4. For cohort 4, patients with NSCLC, HNSCC, RCC, or urothelial carcinoma who are
                  currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have
                  Investigator-assessed disease progression after experiencing SD for at least 6
                  months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor
                  therapy.

               5. For cohort 5, patients that have experienced disease progression by Investigator
                  assessment per irRECIST while receiving treatment in cohorts 1-4.

               6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

               7. Measurable disease by CT or MRI, as defined by RECIST 1.1, except Cohort 5, where
                  non-measurable disease is also allowed

               8. Treatment of at least 3 months (cohort 1-3) or at least 6 months (cohort 4) with
                  checkpoint inhibitor and Investigator-assessed CR or PR (for cohorts 1-3 only) or
                  SD (for cohort 4 only) and ≤ 6 weeks of treatment interruption (cohorts 1-4)
                  immediately prior to study enrollment; treatment in cohort 5 must occur within 1
                  year of discontinuation from cohorts 1-4.

               9. Patients with genomic tumor aberrations should have received prior treatment with
                  an FDA-approved targeted therapy (if available)

              10. Adequate organ system function within 14 days of baseline:

                    -  ANC ≥ 1500 cells/µL (≥1.5 x 10^9 cells/L)

                    -  Platelets ≥ 100,000 cells/µL (≥100 x 10^9 cells/L)

                    -  Hemoglobin > 8 g/dL

                    -  Total bilirubin < 1.0 x ULN

                    -  AST < 1.5 x ULN

                    -  ALT < 1.5 x ULN

                    -  eGFR > 45 mL/min

          3. Age and Reproductive Status

               1. Men and women, ≥ 18 years of age

               2. Women of childbearing potential (WOCBP) must adhere to using a medically accepted
                  method of birth control up to 28 days prior to screening and agree to continue
                  its use during the study or be surgically sterilized (e.g., hysterectomy or tubal
                  ligation) and males must agree to use barrier methods of birth control while on
                  study. WOCBP must agree to use effective contraception during treatment and for
                  at least 5 months following the last dose of study treatment.

               3. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy
                  test during Screening and a negative urine pregnancy test within 24 hours prior
                  to first dose of study treatment (cohorts 1-4); subjects in cohort 5 must have a
                  negative urine pregnancy test at screening and baseline. Non-childbearing is
                  defined as greater than one year postmenopausal or surgically sterilized.

        Exclusion Criteria:

          1. Target Disease Exceptions

             a. Patients with CNS metastases with the following exceptions:

               -  Patient untreated CNS metastases with 4 or fewer sites of disease, with no single
                  site larger than 20mm, are eligible if they are asymptomatic and not requiring
                  steroids at any dose. Patients with asymptomatic CNS metastases may be treated
                  with radiosurgery before or during therapy on trial without treatment delays.

               -  Patients with treated, symptomatic CNS metastases are eligible if they are
                  neurologically returned to baseline (except for residual signs or symptoms
                  related to the CNS treatment) for at least 2 weeks prior to registration AND
                  either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily
                  prednisone (or equivalent).

               -  Patients enrolling in cohort 5

          2. Medical History and Concurrent Diseases

               1. New York Heart Association (NYHA) Class III or IV heart failure, uncontrollable
                  supraventricular arrhythmias, any history of a ventricular arrhythmia, or other
                  clinical signs of severe cardiac dysfunction

               2. Symptomatic congestive heart failure, unstable angina pectoris, or myocardial
                  infarction within 6 months of enrollment

               3. Known autoimmune disease requiring active treatment. Subjects with a condition
                  requiring systemic treatment with either corticosteroids (>10 mg daily prednisone
                  equivalent) or other immunosuppressive medications within 14 days of enrollment
                  are excluded. Inhaled or topical steroids, and adrenal replacement steroid doses
                  < 10 mg daily prednisone equivalent, are permitted in the absence of active
                  autoimmune disease

               4. History of interstitial lung disease and/or immune mediated pneumonitis.

               5. Known HIV-positive

               6. Active systemic infection requiring parenteral antibiotic therapy

               7. Positive hepatitis C serology or active hepatitis B infection

               8. Any ongoing toxicity from prior anti-cancer treatment that, in the judgement of
                  the investigator, may interfere with study treatment. All toxicities attributed
                  to prior anti-cancer therapy other than alopecia and fatigue must resolve to
                  grade 1 (NCI CTCAE version 4) or baseline prior to enrollment. Eligible patients
                  must not require more than 10 mg/day prednisone (or equivalent dose).

               9. Previous malignancies (except non-melanoma skin cancers, in situ bladder cancer,
                  in situ gastric or in situ colon cancers, in situ cervical cancers/dysplasia or
                  breast carcinoma in situ) unless a complete remission was achieved at least 1
                  year prior to study entry and no additional therapy is required or anticipated to
                  be required during the study period. This exclusion does not apply to patients
                  enrolling in cohort 5.

              10. No other illness that in the opinion of the investigator would exclude the
                  subject from participating in the study

          3. Prohibited Treatments and/or Restricted Therapies

               1. Patients in which treatment with PD-1/PD-L1 checkpoint inhibitor is
                  contraindicated

               2. Patients who have received another investigational agent within the previous 3
                  months. This exclusion criteria does not apply to patients enrolling in cohort 5.

          4. Sex and Reproductive Status a. Women who are pregnant or nursing
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Chad Garner, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03228667

Organization ID

CA-ALT-803-02-17


Responsible Party

Sponsor

Study Sponsor

ImmunityBio, Inc.


Study Sponsor

Chad Garner, PhD, Study Director, ImmunityBio, Inc.


Verification Date

May 2021