SBRT + PD-1/PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1/PDL-1 Tx
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Stereotactic radiotherapy; Biological: humanized anti-PD-1 monoclonal antibody; Biological: humanized anti-PD-L1 monoclonal antibody
Intervention description: Treatment will be planned to deliver a total of 18 to 60 Gy to the planning target volume (PTV) in 3 to 5 fractions over 1 to 2 weeks.; Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration; Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Steriotactic Radiotherapy followed by a commercially available PD-1 or PD-L1 inhibitor drug
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if having radiation therapy and continuing
      immunotherapy can improve the benefit of immunotherapy. There have been reports of patients
      who were treated with radiation therapy that not only caused the treated tumors to shrink or
      stop growing, but also resulted in tumors that had not been treated in other parts of the
      body to shrink or stop growing. This effect is thought to be brought about by cells in the
      body's immune system that become active as a result of the effects of radiation therapy. If
      radiation therapy can stimulate the immune system, it may be possible for immunotherapy to be
      helpful again in treating a cancer that the immunotherapy drug helped treat before. This
      study will also check if receiving immunotherapy at the end of radiation therapy has any
      effect on the side effects of radiation therapy or immunotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically-proven diagnosis of a solid tumor malignancy

          -  One of the following criteria must be met:

          -  Clinical or radiographic evidence of disease control (defined as best response of
             stable disease (SD) or partial response (PR) or combination of both for ≥ 16 weeks)
             without evidence of complete response (CR) or progression OR

          -  Clinical or radiographic evidence of disease progression during treatment with PD-1 or
             PD-L1 inhibiting therapy, following previous tumor response (CR, PR, or SD for ≥ 16
             weeks) to PD-1 or PD-L1 inhibiting therapy, and, for patients who discontinued PD-1 or
             PD-L1 inhibiting therapy during response to therapy, disease progression must have
             occurred following at least 8 weeks of re-treatment with PD-1 or PD-L1 inhibiting
             therapy Note: Both the treating medical oncologist and radiation oncologist must be in
             agreement with determination of disease progression.

          -  Administration of a PD-1 or PD-L1 inhibitor within 60 days prior to study registration

          -  Determination by the treating radiation oncologist that the patient is a candidate for
             SRT (ie, radiation therapy with a stereotactic setup) Note: All brain metastases will
             receive stereotactic radiotherapy (SRT).

          -  The total number of tumors requiring SRT must be ≤ 5 Note: Regardless of the number of
             brain metastases that will be treated with SRT, the brain metastases will be
             considered to be one tumor.

          -  Measurable disease by RECIST v1.1 that will not undergo SRT and that is amenable to
             monitoring Note: all brain metastases will receive SRT. Therefore, a patient with
             brain metastases that will be treated with SRT must also have extracranial disease
             that will not undergo SRT and that is amenable to monitoring

          -  Determination by the treating medical oncologist that the patient is a candidate to
             continue the PD-1 or PD-L1 inhibiting therapy that had previously provided disease
             control

          -  Age ≥ 18 years

          -  Karnofsky Performance Status score of ≥ 60 %

          -  A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age
             and has not had a hysterectomy, must have a documented negative serum pregnancy test
             within 14 days prior to initiating study treatment

          -  Ability to understand and willingness to sign the consent form

        Exclusion Criteria:

          -  Other anti-cancer therapy administered between the time of tumor response to PD-1 or
             PD-L1 therapy and time of study enrollment Note: Patients treated with a combination
             of PD-1 or PD-L1 inhibiting therapy and other immunotherapy are eligible; patients
             taking hormonal anti-cancer therapies or steroids for central nervous system (CNS)
             edema management that, in the opinion of the investigator, are appropriate to continue
             are eligible.

          -  Any prior PD-1/PD-L1 therapy-related AE that, in the opinion of the investigator,
             warrants exclusion from participation in this trial

          -  Administration of any investigational agent within 4 weeks prior to initiating study
             treatment

          -  Known active hepatitis B or C

          -  Pregnancy or breastfeeding

          -  Medical, psychological, or social condition that, in the opinion of the investigator,
             may increase the patient's risk or limit the patient's adherence with study
             requirements